Hyclens Surgery

Evidence-based guidelines for chlorhexidine gluconate in
Title preoperative skin preparation to reduce surgical site infection in

patients undergoing general surgery
Author(s) Lai, Shuk-tin; 黎淑鈿
Citation
Issued Date 2013
URL http://hdl.handle.net/10722/193047
Rights Creative Commons: Attribution 3.0 Hong Kong License

Abstract of thesis entitled
“Evidence-based Guidelines for Chlorhexidine Gluconate in Preoperative Skin Preparation
to Reduce Surgical Site Infection in Patients Undergoing General Surgery”
Submitted by
Lai, Shuk Tin
for the degree of Master of Nursing
at The University of Hong Kong
in August 2013
Surgical site infection not only brings morbidity and mortality to patients, but it also bring
substantial financial burden to the hospital and the healthcare system. To minimize the clinical
consequences of surgical site infection, it is crucial that all appropriate measures for reduction of
surgical site infection should be implemented. Since patient’s skin is a potential source of
pathogens, normal skin flora isa common cause of surgical site infections. Preoperative skin
disinfection of the surgical site with an antiseptic agent is an effective method to remove the soil
and transient organisms from the skin.Currently, there are different skin antiseptics available and
the most commonly used agents are povidone iodine and chlorhexidine gluconate. Although
povidone iodine has a long-standing recommendation and it is widely used in various surgical
procedures, it has several limitations.On the other hand, there isan increasing interest of the use
i
of chlorhexidine in indwelling catheter placement and care, surgical hand scrubbing, as well as
wound dressing.
In view of this, there is a potential of replacing povidone iodine by chlorhexidine as
preoperative skin antiseptic agent. As there is no existing guideline supportingthis innovative
movement, this dissertation aimed to review the currently available evidence on preoperative
skin preparation and to develop an evidence-based guideline of using chlorhexidine in
preoperative skin preparation for reducing surgical site infection in patients undergoing general
surgery.
Five randomized controlled studies were identified from MEDLINE, CINAHL and
PUBMED and evaluated by a critical appraisal tool, the Scottish Intercollegiate Guidelines
Network. All studies reported that preoperative skin preparation with chlorhexidine is more
effective than the use of povidone iodine in reducing surgical site infection. Anevidence-based
guidelineis developed according to the guideline development process from the Scottish
Intercollegiate Guideline Network. Patient characteristics, local clinical setting, organizational
infrastructure and staff competency is congruent with the proposed innovation. The new protocol
not only can minimize the risk of postoperative surgical site infection but also save costs. The
cost-benefit analysis showed that the new protocol can help to save $675,552 to $1,097,772 (HK
dollars) in six-month period after implementation.
To facilitate a more comprehensive plan in actual implementation of the proposed guideline,
stakeholders at administrative, managerial, and operational levels would be invited to take part in
ii
the 12-week pilot test.Surgical site infection, staff satisfaction and compliance, as well as cost
and benefit ratio of the guideline would be measured in the evaluation plan. The refined
guidelines would then be implemented for one year. The effectiveness of the guidelinewould be
determined by reduction in postoperative surgical site infection, increase in staff knowledge and
satisfaction, and the overall expenditure.
iii
Evidence-based Guidelines for Chlorhexidine Gluconate in Preoperative Skin Preparation
to Reduce Surgical Site Infection in Patients Undergoing General Surgery”
by
Lai Shuk Tin
R.N., B.N.
A thesis submitted in partial fulfillment of the requirements for

the Degree of Master of Nursing
at the University of Hong Kong.
August, 2013
iv
DECLARATION
I declare that this dissertation represents my own work, and that it has not beenpreviously
included in a thesis, dissertation or report submitted to this University or to any other institution
for a degree, diploma or other qualifications.
___________________________________
Lai, Shuk Tin
September 2013
i
ACHKNOWLEDGEMENTS
I would like to take this opportunity to express my gratitude to mysupervisors, Dr. Daniel
Yee-Tak Fong and Dr.Dennis Chow for their enlightenment, guidance and patience throughout
my long and hard journey for this dissertation and the whole master studies.
I am also grateful to my family and classmates who showed me their support and
encouragement during my study in the Master of Nursing degree course.
ii
CONTENTS
Declaration ……….………………………………………………………………………….. i
Acknowledgements …………………………………………………………………………… ii
Table of Contents …………………………………………………………………………….. iii
List of Illustration…………………………………………….………………………………. v
CHAPTER 1: INTRODUCTION
1.1 Background ………………………………………………………………... 1
1.2 Affirming Needs ………………………………………………………...… 2
1.3 Objectives & Significance ………………...………………………………. 5
CHAPTER 2: CRITCAL APPRAISAL
2.1 Search & Appraisal Strategies ………………………………...................... 7
2.1.1 Identification of studies
2.1.2 Selection Criteria
2.1.3 Data Extraction
2.1.4Appraisal Strategies
2.2 Results…………….……………………………………..………………… 9
2.2.1 Search Results
2.2.2 Study Characteristics
iii
2.2.3 Methodology Quality Assessment
2.3 Summary & Synthesis …………………………………………………….. 14
2.3.1 Summary
2.3.2 Synthesis
CHAPTER 3: TRNSLATION AND APPLICATION
3.1 Implementation Period ……………………..……………………………... 19
3.1.1 Transferability of the findings
3.1.2 Feasibility
3.1.3 Cost-benefit ratio of the innovation
3.2 Evidence-based Protocol………………........………..………………….… 26
CHAPTER 4: IMPLEMENTATION PLAN
4.1 Communication Plan...……………………..……..……………………….. 27
4.1.1 Identification of Stakeholders
4.1.2 Communication Process and Strategies
4.2 Pilot Study Plan……………………………………………………………. 29
4.2.1 Objectives
4.2.2 Target Setting and Population
4.2.3 Time Frame
4.2.4 Outcomes Measure
iv
4.2.5 Data Collection
4.2.6 Analysis and Evaluation of the Pilot Test Results
4.3 Evaluation Plan……………………………………………………………. 32
4.3.1 Outcomes
4.3.2 Nature of Subjects
4.3.3 Sample Size
4.3.4 Timing and Frequency of Outcome Measurement
4.3.5 Analysis of Data
4.3.6 Criteria for Determining Guideline Effectiveness
APPENDICES
I Evidence table ………………………………….................................................... 37
II SIGNS Methodology Checklist………………………………………………....... 38
III SIGNS Level of Evidence……………………………………………….……...... 40
IV Quality assessment for individual study ………………………………….…...…. 41
V Estimated set up cost of the new guideline……………........................................ 51
VI Estimated saving from the new guideline.………………………………….…….. 52
VII The evidence-based guideline……………………………………………….…..... 53
VIII Timeline and Communication Plan ………………..………………………….…. 59
IX Data collection sheet.………………………………………………………..…..... 60
X Staff survey …………………………………………………………………….… 61
v
REFERENCES ……………………………………………………………..…………… 62
vi
CHAPTER 1
INTRODUCTION
1.1 Background
The Centers for Disease Control and Prevention reported that surgical site infections
made up 14% to 16% of all infections and it is the third most frequently reported hospital-
acquired infection worldwide (Centers for Disease Control and Prevention, 2009). Surgical site
infection delays the recovery and may inflict serious adverseimpact on surgical patients. Patients
with postoperative surgical site infection not only suffer from increased pain and physical
discomfort, they are their family members may also have a decreased quality of life (Biscione,
2009). Moreover, there are other short-term and long-term negative consequences. For patients
with infective complications, their survival rate after an operation is significantly lower than in
patients without infection (Nespoli et al, 2006). In addition, it has been reported that patients
with surgical site infection are 1.9 times more likely to have an incisional hernia (Murray et al,
2011). Apart from the clinical adverse consequences, surgical site infection increases the
financial burden on both patients and hospitals. Graf et al. (2011) reported that surgical site
infection almost tripled the individual costs on medical treatment. The delayed recovery one one
hand hinders the patient from resuming work and thus reduces her productivity. One the other
hand, the additional stay in hospital increases her expenditure onmedical and surgical treatment
and also pain management. Other additional expense include the extra money needed from her
family caregiver on visiting and subsequent follow-up visit to doctors. Prolonged hospital stay
1
also increases patients’ risk of other adverse health outcomes (e.g. pressure ulcers, medication
reactions, or use of urinary or other indwelling catheters).All these adversities could result in
subsequent hospital-acquired infections (Graf et al., 2011). de Lissovoy et al. (2009) revealed
that that, depending on the types of surgery, surgical site infection raised hospital stay by 9.7
days and the cost treatment by $20,842 (US dollars). Additionally, in both public and private
hospitals, surgical site infection increases hospital costs significantly (Dimick et al, 2004).
1.2 Affirming the Needs
Of an operation theater in a private hospital of Hong Kong which carries out different types
of operations, the overall surgical site infection rate ranges from 3.1% to 7% in 2011 (Infection
control team, 2011). This rate is comparable to other hospitals in Hong Kong. However, since
surgical site infection is an unwanted postoperative outcome which brings serious adverse
consequences and huge financial burden to both surgical patients and hospitals, further effort
should be made to eradicate this problematic issue.
To minimize the clinical consequences of surgical site infection, it is crucial that all
appropriate measures are implemented (Biscione, 2009). In the local setting, preventive measures
such as environmental control, instruments sterilization, sterile techniques, and administration of
perioperative antibiotics have been implemented to keep surgical wound from being
contaminated by infectious organisms. However, despite all the effort, the risk of postoperative
infection has not been eradicated. Since patient’s skin is a potential source of pathogens, Normal
skin flora including staphylococcus aureus and coagulase-negative staphylococci, are common
2
causes of surgical site infections (Bhavan & Warren, 2009). Therefore, preoperative skin
preparation has an important role in preventing surgical site infection.
Preoperative skin disinfection of the surgical site with an antiseptic agent is an effective
method to remove the soil and transient organisms from the skin (AORN Standard, 2006).
Antiseptic skin preparation products are formulated to quickly kill a wide spectrum of pathogens
and to provide a persistent and high level of antimicrobial action (Digison, 2007). Currently,
there are different skin antiseptics available and the most commonly used agents are povidone
iodine and chlorhexidine (Lepor & Madyoon, 2009). As the antiseptic agents has various
capabilities on removing and destroying pathogens on patient skins, adequate selection is critical
for the prevention of surgical site infection.
In local departments, povidone iodine is routinely used for skin preparation for most of the
open general surgeries. Povidone iodine performs its antiseptic action by releasing free iodine
and that binds to microbes, resulting in destruction of their cellular structures and enzymes
(Chernesky & Mahoney, 1990). Despite its longstanding recommendation and popularity, it has
several limitations. First, it causes redness on patient’s skin. In addition, as it only has a moderate
action, the drying time for an optimal antiseptic function, on average, is 3 minutes (Zinn et al,
2010). However, operation is always under a quick pace, patient’s skin is often dried with sterile
towel and incised before an optimal disinfection. This greatly hinders the function of povidone
iodine on antiseptic skin preparation. Moreover, the brown color of povidone iodine stains
patient’s skin even after several hours of the operation. Extra effort is needed for removing the
stain postoperatively and this increases risk of skin irritation or local pain. Recently, a surgeon
3
reported that povidone iodine stain was found at the back of his patient 4-to-5 days after the
breast surgery. This might be due to an incomplete removal of the povidone iodine solution
postoperatively. Since surgical patient was prohibited from bathing, the delay can make the
removal even harder.
There has been an increasing interest in the use of chlorhexidine worldwide. It kills
microbes by destructing their cell membranes and thus causing leakage of the cellular contents
(Chernesky & Mahoney, 1990). In recent year, extensive studies have compared chlorhexidine
and povidone iodine on their antiseptic power. The use of chlorhexidine has demonstrated lower
bacterial count and better infection prevention in indwelling catheter placement and care
(Munoz-Price et al, 2012), surgical hand scrubbing (Lai et al, 2012), and wound dressing
(Eardley, Watts, & Clasper, 2012). Furthermore, immediate skin incision can be done after using
chlorhexidine in skin preparation as it does not require a waiting time for action (Zinn et al,
2010). It is much more time saving and, even in emergency surgical procedures, antiseptic power
can be ensured. In view of this, there is a potential of replacing povidone iodine by chlorhexidine
as preoperative skin antiseptic agent.
Surgical site infection not only brings morbidity and mortality to patients but also
substantial financial burden to the hospital and the healthcare system. Perioperative nurse plays
an important role in minimizing the incidence of surgical site infection by rigorous adherence to
aseptic techniques and also respond quickly to the most updated evidence-based practice. This
paper reviewed the available evidence on preoperative skin preparation and aims to develop
4
evidence-based guidelines of using chlorhexidine in preoperative skin preparation for reducing
surgical site infection in patients undergoing general surgery.
1.3 Objectives & Significance
In response to the need of an evidence-based guideline using chlorhexidine in preoperative
skin preparation, the following objectives would be achieved in this dissertation.
1. To systematically evaluate the current evidence on the use of povidone iodine and
chlorhexidine in preoperative skin preparation.
2. To develop an evidence-based practical guideline on using chlorhexidine in preoperative
skin preparation for general surgery.
3. To assess the transferability and feasibility of implementing the evidence-based practical
guideline in a local hospital.
4. To develop an implementation and evaluation plan for the use of the evidence-based
practical guideline in a local hospital.
By implementing an effective evidence-based practical guideline, the incidence of surgical
site infection can be greatly reduced. Since adverse postoperative outcomes are minimized,
surgical patients and their caregivers can resume their normal lives as soon as possible. This is
beneficial in both physical and psychological aspects. For healthcare professionals, time could be
saved on preoperative skin disinfection and postoperative cleaning of patient skin. For
5
economical concern, additional medical cost due to infection can be save and the hospital can use
the recourses for other constructive development.
6
CHAPTER 2
CRITICAL APPRAISAL
2.1 Search Strategies
2.1.1 Identification of studies
For identification of studies, electronic databases including Medline, PubMed and
CINHAL were systematically searched in July 2012 with keywords “chlorhexidine”, “povidone
iodine” and “surgical wound infection”. A constraint was set for studies with human species,
adults aged 18 or above, and randomized control trial. Manuscripts published in any languages
were included in the search. After the search, titles and abstracts of the retrieved manuscripts
were carefully screened. For those satisfied the inclusion criteria, their full texts were reviewed
for eligibility. Manual search of the reference lists of the eligible studies was also performed for
identifying any additional relevant studies.
2.1.2 Selection Criteria
Studies were included if they meet the following inclusion criteria:
1. Participants of the study were adult surgical patients who were subjected to general
surgery;
2. Chlorhexidine and povidone iodine were compared;
3. Surgical site infection was considered as an outcome measure; and
4. Study design was randomized controlled trial (RCT).
7
Studies were excluded if they meet the following exclusion criteria:
1. Study concerning only bacterial load or skin flora count;
2. Study used chlorhexidine and povidone iodine for surgical hand scrubbing, wound
dressing, preoperative shower, intraoperative peritoneal lavage, indwelling catheter care
and mouth care; or-
3. Study considering patients undergoing laparoscopic surgery only.
2.1.3 Data Extraction
Information of the eligible studies were extracted for further analysis. These information
include study design, characteristics of participants, intervention and control, application method
of the solutions, length of follow up, outcome measures such as surgical site infection rate,
bacterial colonization and colony-forming units, and the effect size. Table II provides a summary
of the extracted data from the reviewed studies.
2.1.4 Appraisal Strategies
The Scottish Intercollegiate Guidelines Network (SIGNS, 2012), a critical appraisal tool,
was used for the evaluation. The SIGN methodology checklist is a reliable tool which aids a
systematic review of current evidence and development of an evidence-based clinical guideline.
The individualized checklist for randomized control trials provided a comprehensive assessment
on the research question, randomization method, concealment method, comparability of groups,
internal validity, methodology and the generalizability of the study results. After assessing the
methodological quality, level of evidence of the study was rated by a coding system, “++”, “+”
8
or “-“. The SIGNS methodology checklist for quality appraisal and its guideline for Level of
Evidence can be found in Appendix I and II respectively. All included studies were
systematically reviewed in accordance to the SIGNS checklist and details can be found in
Appendix IV.
2.2 Results
2.2.1 Search Results
The search was conducted in August, 2012. Based on the search from the three electronic
databases, 172 manuscripts were identified and, after initial screening, 32 were retained. A
secondary screening focusing on the titles and the abstracts further reduced the result to 10
manuscripts. Reasons of the exclusion is: The intervention, participates or outcome measures of
the study reported in these manuscripts do not match the inclusion criteria. Among the 10
manuscripts, some reported on the same study and one reported a cohort study and were thus
excluded. Hence, 4 eligible studies were yielded from the database search. Furthermore, manual
search of the systematic review and the eligible studies was done and one additional study was
identified. Therefore, there were in total 5 studies included. The searching plan is presented in
the following flow chart diagram (Figure I). To give a clearer picture of the searching plan, the
search results from each electronic databases and table of search results are presented in table I.
9
Figure I. Flow chart of searching strategy
Medline PudMed CINHAL
Key words search:

“chlohexidine” AND
“povidone iodine” AND
61 75 36
“surgical wound infection”
Limit to: “human” and “adult” 19 23 6
Limit to: “RCT” 13 14 6
Exclude negligible studies Repeated study: 1 Repeated study: 0 Repeated study: 0

Excluded: 8 Excluded: 10 Excluded: 5
4 4 1
Merge results 4
Exclude repeated studies
Manual search of reference list Eligible studies: 1
Total included studies 5 RCTs
10
Table I. Table of search results
Exclude
Electronic database
Population not Outcome not

Intervention not matched
matched matched
Wound dressing
Other antiseptic
Citations of final search Study
Pre-op shower
Bacterial load
Surgical hand
catheter care
No Include
Skin culture
Mouth care
Pacemaker
Indwelling
Peritoneal
morbidity
result type not
Febrile
lavage
agents
scrub
care
matched
1 Darouiche et al., 2010 ●

2 Paocharoen et al, 2009 ●
3 Berry et al., 1982 ●
4 Bibbo et al., 2005 ●
5 Brooks et al., 2001 ●
Medline
6 Cheng et al., 2009 ●

7 Veiga et al., 2008 ●
8 Kalantar-Hormozi et al., 2005 ● ●
9 Stahl et al., 2007 ● ●
10 Sistla et al., 2010 ●
11 Sowapat et al., 2006 ●
12 Vallance, & Waldron, 1985 ● ●
2 Paocharoen et al, 2009 ●
3 Parienti et al., 2009 ●
4 Berry et al., 1982 ●
5 Bibbi et al., 2005 ●
6 Brooks, 2001 ●
PubMed
7 Cheng et al., 2009 ●

8 Veiga et al., 2008 ●
9 Kalantar-Hormozi et al., 2005 ● ●
10 Saltzman et al., 2009 ●
11 Stahl et al., 2007 ● ●
12 Sistla et al., 2010 ●
13 Sowapat et al., 2006 ●
14 Vallance, & Waldron, 1985 ● ●
1 Alfzal et al., 2009 ●
CINAHL
3 Bibbi et al., 2005 ●

4 Bonatti et al., 2009 ●
5 Ramsdale et al., 1984 ●
6 Saltzman et al., 2009 ●
1 Brown et al., 1984 ●
Manual
search
11
2.2.2 Study Characteristics
The eligible RCTs were conducted between year 1982 and 2010 in the United Kingdom
(Berry et al., 1982), India (Paocharoen et al, 2009), Thailand (Sistla et al., 2010) and the United
States (Darouiche et al., 2010; Brown et al., 1984).
All studies compared the efficacy of chlorhexidine and povidone iodine on postoperative
surgical site infection. Success of obtaining ethical approval is reported in three studies. Study
characteristics are summarized in the table of evidence (Table II). Study participants were adult
surgical patients underwent general surgeries. Only one study focused on one type of surgery,
herniorrhaphy (Sistla et al., 2010). All studies used chlorhexdine as the test and povidone iodine
as the control treatment. The application methods of the two solutions were clearly stated. Four
reviewed studies reported the length of the follow-up period, ranging from 3-to-4 days to 1
month. One study however did not mention about the length of the follow-up (Brown et al.,
1984). In addition to the outcome of surgical site infection rate, some studies further classified
infection into different types (e.g. superficial incisional, deep incisional, organ space and sepsis).
Other outcomes measured in these studies include postoperative length of stay, bacterial counts
and allergy reaction.
2.2.3 Methodology Quality Assessment
Of the 5 RCTs, the methodology used in one study was in high quality (Darouiche et al.,
2010); three were moderate (Berry et al., 1982; Brown et al, 1984; Sistla et al., 2010); and one
was poor (Paocharoen et al., 2009). Assessments of the quality of each study are listed in
Appendix III.
12
The focused questions were clearly stated in all studies. Regarding randomization, the
utilized methods included computer-generated stratification (Darouiche et al., 2010), random
number table (Berry et al, 1982), and stratified randomization (Brown et al., 1984). Two studies
on the other hand did not report details of the randomization process (Paocharoen et al., 2009;
Sistla et al 2010). For concealment method, only one study did not report it (Paocharoen et al.,
2009). Three studies used sealed envelopes method (Berry et al, 1982; Brown et al., 1984; Sistla
et al 2010) and one used centralized allocation (Darouiche et al., 2010) to keep the researchers
and participants unaware of the treatment group allocation. For blinding method, two studies
stated that participants and investigators were unaware of treatment group assignment throughout
the study (Darouiche et al., 2010; Sistla et al 2010).
The sample size of the studies were all over 400 and sample size calculation was only
reported in the study of Darouiche et al. (2010). For baseline measures (i.e. demographic factors,
preoperative conditions, coexisting health problems, duration and type of surgery and risk factors
for infection), all studies reported no significant differences between patients in the intervention
and control groups. Most of the studies standardized the preoperative use of antibiotics in order
to control the difference between the two groups. However, in the study conducted by Brown et
al. (1984), operating surgeons were allowed to decide their choice of systemic antibiotic and this
might be a potential confounding variable that jeopardizes the validity of their study results.
All the primary and secondary outcomes were clearly stated and they were measured in a
standardized method. All studies reported that they use the guideline of wound assessment
developed by Center of Disease and Control for assessing surgical wounds postoperatively. In
13
three of the studies (Berry et al., 1982; Brown et al, 1984; Darouiche et al., 2010;), the surgical
wounds of both study groups were assessed and documented by the same group of investigators
and this minimized the bias due to the difference of individual perception. Assessment of
surgical wounds in Paocharoen et al.’s study (2009) was relied on surgeons’ own judgment and
this could reduce the inter-rater reliability. Questionnaires were used to record surgical site
infection in the study by Sistla et al., (2010). The method of self-repot for data collection was
susceptible to the response bias and misunderstanding.
Concerning the dropout rate, the study of Paocharoen et al. (2009) claimed that there was
no dropout whereas, in the study of Darouiche et al. (2010), two dropouts in each study group
was reported. Sisla et al (2010) reported the dropout rate in their study was less than 5 %. The
amount of missing value across these three studies was small and thus it is unlikely to affect their
study outcomes. The other two studies did not mention their dropout rates (Berry et al., 1982;
Brown et al, 1984). The intention-to-treat principle was only adopted in Darouiche et al. (2010)
but not in other studies. In addition, Darouiche et al.’s study (2010) was the only one carried out
in multiple sites so its generalizability was comparatively greater than the other studies.
2.3 Summary & Synthesis
2.3.1 Summary
All five studies compared chlorhexidine with povidone iodine and evaluated their efficacy
on the prevention of surgical site infection. In these studies, chlorhexidine in concentration
ranged from 0.5% to 4% in 70% alcohol and povidone iodine in concentration of 10% were used.
14
The application method varied across studies. Two studies used simply painting (Berry et al.,
1982; Sistla et al., 2010) and other studies used painting together with scrubbing (Darouiche et
al., 2010; Brown et al, 1984; Paocharoen et al., 2009). Only two studies mentioned about the
scrubbing and painting time, which ranged from 5 minutes (Paocharoen et al., 2009) to 6 minutes
(Brown et al., 1984). Moreover, four studies used the liquid form of chlorhexdine whereas one
used the spray form (Brown et al, 1984).
All studies reported that preoperative skin preparation with chlorhexidine is more effective
in reducing surgical site infection than using povidone iodine (Darouiche et al., 2010;
Paocharoen et al, 2009; Berry et al., 1982; Brown et al., 1984; Prabhu et al., 2010). The
additional reduction was significant except in studies of Sistla et al. (2010) and Paocharoen et al.
(2009). When the two solutions were compared on the level of infections, studies showed that
chlorhexidine had a significant greater action on superficial incisional wound (P=0.008), deep
incisional wound (P=0.04) (Darouiche et al., 2010), and hematoma (P=0.044) (Brown et al.,
1984). A lesser difference between the two solutions was observed on organ space (P=0.0919),
sepsis (P=0.199) (Darouiche et al., 2010), and wound separation (P=0.120) (Brown et al., 1984).
Two studies also compared the solutions by bacterial counts. Postoperative bacterial count were
significantly lower with the use of chlorhexidine (P<0.0002) (Paocharoen et al, 2009), but the
effect of the solutions in the overall reduction of bacterial counts (P=0.787) (Sistla et al., 2010)
and bacterial growth (Berry et al., 1982) was not significantly different. Concerning the types of
infectious organisms, Paocharoen et al. (2009) demonstrated that chlorhexidine had a better
effect on staphylococcus epidermidis (P=0.0009), staphylococcus aureus (P=0.201),
streptococcus species (P=0.024) and enterococcus species (P=0.316).
15
One study reported two allergy cases in the povidone iodine group and none was observed
in the chlorhexidine group (Paocharoen et al, 2009). Sistla et al. (2010) found that patients with
preoperative stay for more than 48 hours had a significantly higher risk of having allergy than
those with stay less than 48 hours (P=0.001).
2.3.2 Syntheses
From the current evidence, three studies found a significant difference between the two
solutions and the methodology of these studies were in high- (Darouiche et al., 2010) or
moderate-quality (Berry et al., 1982; Brown et al., 1984). The other two studies reported no
significant differences (Paocharoen et al., 2009; Sistla et al., 2010) and that might be due to the
following reasons. Firstly, the data collection methods of the two studies were of high risk of
bias. Paocharoen et al. (2009) relied on surgeons’ assessment on their own patients’ wounds and
this assessment method might potentially jeopardize the validity of the study. In particular, since
surgeons were not blinded in data collection and they knew which solution had been used for
their own patients, there are possibility that they deliberately favored their choice of antiseptic
solution. Sistla et al. (2010) used patient self-report questionnaires for data collection which
misunderstanding of questionnaires, improper judgment on surgical wound infection and
unresponsive participants were possible. The data collection methods of the two studies were at
high risk of underestimating the measuring outcome. Secondly, the study of Sistla et al. (2010)
focused only on hernia surgery, which is a type of clean surgery with low risk of surgical site
infection. Due to the lesser incidence of surgical site infection, their study may have insufficient
statistical power to detect the true difference between the solutions.
16
Of the three studies reporting significantly lower surgical site infection in patients treated
by chlorhexidine, similar effect sizes were observed in two studies (Darouiche et al., 2010;
Brown et al., 1984) whereas the other study (Berry et al., 1982) showed a smaller effect size. In
the study conducted by Berry et al. (1982), the application method of the antiseptic solutions was
simply painting whereas the other two studies used scrubbing together with painting. This
suggested that chlorhexidine was more effective in reducing surgical site infection when it was
scrubbed as well as painted on patients’ skin preoperatively.
Preparation of chlorhexidine was also an important factor for prevention of surgical site
infection. Across all studies, chlorhexidine solution was prepared with 70% alcohol, except
Berry et al.’s study (1982) which used plain chlorhexidine solution. For studies using 0.5%
concentration, chlorhexidine was prepared in spray form (Brown et al, 1984) and, compared with
other studies, the effect size on infection rate was relatively small (Berry et al., 1982). Study
using 4% concentration (Paocharoen, et al., 2009) also had a smaller effect size on infection rate
than studies using concentration of 2% (Darouiche, et al., 2010; Sistla, et al., 2010). Concerning
the form of chlorhexidine, the usual preparation was in liquid form. However, the study of
Brown et al. (1984) suggested the use of chlorhexidine spray was more user-friendly and time-
saving. The chlorhexidine spray might be especially useful for emergency. However, the optimal
amount and techniques of application were in doubt. Therefore, based on the study results, it is
preferable to use 2% chlorhexidine with 70% alcohol for preoperative skin preparation in general
surgery for reducing surgical site infection.
17
In 2010, a meta-analysis of clinical trials conducted by Noorani et al. concluded that
chlorhexidine for preoperative skin cleansing was superior to povidone iodine in decreasing
postoperative surgical site infection after clean contaminated surgery. The evidence reviewed in
this paper, which focused on RCTs, is consistent with the result of the meta-analysis and it
further advocates the use of chlorhexidine from clean contaminated surgery in general surgery.
Based on the current evidence, chlorhexidine is proven to be more effective than povidone iodine
in reducing surgical site infection at different levels; decreasing preoperative bacterial
colonization; inhibiting bacterial growth; and lowering postoperative bacterial count. In addition,
it was at lower risk of chemical allergy and no color staining problem on patients’ skin after
operation. Although the choice of preoperative skin aseptic solutions was usually considered by
surgeons, nurses should be responsible to continuously update clinical knowledge and actively
promote the change of evidence-based practice so as to ensure the best outcome for patients.
From the systematic review of the current studies on preoperative skin preparation for general
patients, it was obvious that mounting high-quality evidence supports the use of chlorhexidine
rather than povidone iodine for reducing postoperative surgical site infection.
To conclude, there is sufficient evidence to support the change of povidone iodine to
chlorhexidine for preoperative skin preparation. Chlorhexidine of concentration 2% in 70%
alcohol with the technique of scrubbing and painting is recommended for preoperative skin
preparation to prevent surgical site infection in patients undergoing general surgery.
18
CHAPTER 3
TRANSLATION AND APPLICATION
3.1 Implementation potential
The systematic evaluation of the contemporary literature revealed that sufficient evidence
supporting chlorhexidine is more effective than povidone iodine in reducing postoperative
surgical site infection. For the sake of patient and advancement of the organization, it is worth to
consider the implementation of this innovation. To evaluate its implementation potential in the
local setting, transferability of the findings from previous studies, feasibility and cost-benefit
ratio of implementing the innovation will be evaluated in this chapter.
3.1.1 Transferability of the findings
The motto of the local hospital is “quality in service and excellence in care”. It is the
responsibility to continually review current services and practices for ensuring both quality and
integrity, as well as constantly strive for better patient care. The proposed guideline provides an
evidence-based evolution on preoperative skin preparation with an aim to reduce the incidence of
surgical site infection and minimize the adverse postoperative outcomes for surgical patients. For
the sake of high standard patient care, the philosophy of care underlying this innovation in
parallel with the philosophy prevailing in the practice setting.
The local setting is an operating theater of a local private hospital. In this setting, various
types of operations including robotic assisted surgeries, laparoscopic surgeries, orthopedic and
19
trauma surgeries, vascular surgeries, endoscopy, and general surgeries (colorectal,
gastroesophageal, hepatobiliary, thoracic, gynecologic, urologic, ophthalmic, head and neck) are
performed for both adult and pediatric patients. Since no statistical data are available from the
hospital, on-site clinical observation and data collection were performed from November 2011 to
November 2012. It was found that there were approximately 1440 operations performed per
month and 65% were open general surgeries. Among these surgeries, 97% were performed on
adult patients. Compared to the reviewed studies (Darouiche et al., 2010; Paocharoen et al, 2009;
Berry et al., 1982; Brown et al., 1984; Prabhu et al., 2010), their studies were conducted in an
operation room of a hospital, which is similar to the local setting. Besides, the participants of
their studies were also adult surgical patients who aged over 18 and underwent open general
surgeries. In this sense, both clinical environment and demographic characteristics of the target
population in the local setting are similar to the identified studies.
Since characteristics of the target population and philosophy of care are similar, the
findings of the five identified studies are transferrable to the local setting. Based on on-site
observation, there are over ten thousand surgical adult patients undergoing open general
operations in the setting each year. Additionally, there is a growing trend for patient moving
from the public hospitals to private hospitals for surgical advice. If the proposed guideline is
implemented, it will benefit sufficiently large number of clients in the practice setting.
The proposed guideline will not take too long to implement and evaluate. It requires one
month for preparation of materials, training of nursing staff, as well as promotion to surgeons.
Then the preparation period will be followed by a pilot period which requires one month for trial
20
and refinements. In this stage, improvements will be done after receiving feedbacks from
surgeons and nursing staff. After preparation and pilot, the new protocol will be implemented.
Nursing staffs and surgeons will be advised to follow the guideline strictly and data collection
for postoperative surgical site infection will be performed. During the implementation period, the
department manager can stop implementing the guideline if it is found to be not effective in the
local settings.
3.1.2 Feasibility
Currently, povidone iodine is used as the preoperative skin antiseptic solution for most of
the operations, except cystoscopy, hysteroscopy, or some minor gynecological operations (e.g.
termination of pregnancy and transcervical resection of uterine fibroid). The main idea of the
proposed guideline is to replace povidone iodine by chlorhexidine in all open general surgeries in
order to minimize the incidence of postoperative wound infection. The project director of this
project will be the manager of the department. She will be responsible for the final evaluation
and has the right to approve and terminate the project. Three leaders, which will be assigned by
the department manager, are required for project organization. They will be a senior nursing staff
in the department. Apart from coordinating the necessary medical equipment, they are also
responsible for the training and promotion for the new guideline. Besides, they need to perform
evaluation of the project after data collection in regards to nursing staffs’ performance and
surgeons’ adherence to the new guideline. In addition, the project leaders will serve as an
important bridge for effective communication between the project leader and all other nursing
staffs. To ensure a high standard of preoperative skin preparation through this new guideline, all
the nursing staffs will be given a training session focusing on the introduction of the evidence-
21
based guideline and technique of skin preparation. In the local setting, all the nursing staffs are
divided into six groups with each group consisting of about eighteen staffs. The nursing officer
in each group will assign one senior staff as the project coordinator. They have to attend an
informative talk organized by the project coordinators. Then, they will help disseminating the
information and provide training to their group members during group meeting. They are asked
to observe their group members continually during every day work and report the findings to the
project leaders. Since the staff meeting is usually organized after work, no extra time or
manpower will be needed.
After the explanation of the rationale of change, nurses in the local setting are encouraged
to follow the guideline in a strict manner. They play an important role in promoting this new
practice and assist the surgeons for using the new antiseptic solution. Certainly, whenever
unsuitable situation is identified, surgeons can terminate the practice autonomously. Since the
proposed guideline only focuses on the preoperative skin preparation procedure, no additional
workload is required. In other words, current nursing procedures and surgical practices will not
be greatly disturbed or interfered. Therefore, the implementation of the innovation will not
interfere inordinately with current nursing staffs functions. Besides, as the training sessions for
nursing staffs will be carried during the monthly group meeting, no extra working hours will not
be required.
The innovation would be supported at the administrative level. The great success of
“surgical time out” protocol conducted in the local setting last year is a good example of
organizational support to research utilization and evidence-based practice. However, surgeons, to
22
some extent, may resist and being uncooperative as they may be reluctant to change their usual
practice and fail to recognize the rational of the new practice. The administrative department can
support the new guideline by sending email, launching promotional talks, together with
organizing discussion to inform surgeons the new practice, and gathering feedbacks. Based on
previous experience of conducting and implementing various evidence-based protocols, all
members in the setting including the administrators, nursing staffs, in-house surgeons and
anesthesiologists would reach a common agreement on the importance of continual refinement
on patient care.
For equipment and facilities for the innovation, the main concern is the choice of the
chlorhexidine solution concentration. From the literature review, chlorhexidine of 2%
concentration in 70% alcohol is recommended. However, it is currently not available in the
hospital. Project coordinators are responsible to consult the pharmacy department about the
choice of manufacturer and the logistic affairs. In addition, computer for PowerPoint
presentation and a room for real time practice will be required for staff training.
After the proposed guideline is implemented for a six-month-period, the effectiveness of
the proposed guideline will be evaluated based on three outcomes: the incidence of postoperative
surgical wound infection, the compliance of the new practice, and the ability of the staff to
demonstrate proper preoperative skin preparation. All the skills and equipment for measuring
these outcomes are available in the hospital. Adherence of the new guideline and ability of
surgeons and nursing staff will be measured by the project coordinators in the local setting. At
the same time, in order to encourage the participation of other parties in the hospital, incidence of
23
postoperative surgical site infection will be recorded by the ward nurses and the data collection
will be monitored by the infection control team.
3.1.3 Cost-benefit ratio of the innovation
The major benefits resulted from the new protocol is the reduction of postoperative wound
infection rate and the improvement of patients’ surgical outcome. By minimizing the surgical
complications, healthcare cost can be greatly reduced. More importantly, motivating all nursing
staffs, surgeons and anesthetists to participate in the evidence-based practice can widen their
insight on clinical advances. The standard of the department and the image of hospital will also
be enhanced in the society. A positive image will strengthen customers’ confidence and it is an
effective public promotion for the hospital.
On the other hand, the implementation of the new protocol may result with adversity for
patients and the local setting. Although allergy cases have only been observed from the povidone
iodine group but not the chlorhexidine group (Paocharoen et al, 2009), hypersensitivity to the
chlorhexidine solution is possible. Besides, the local setting may be subjected to resistance and
complaints from surgeons due to their reluctance to the change of the usual practice. However,
for the sake of best patient care and the long term improvement of the hospital standard, the local
setting is encouraged to terminate current practice and try to explain the benefit to the reluctants.
One of the most concerning area of the new practice is the cost. The set-up cost of the
project includes the cost of manpower and material. Details of the estimates are listed in
Appendix IV. All the nursing staffs in the department has their role and responsibility in the new
24
guideline and they are part of the manpower cost. For the cost of the material, there are short-
term and long-term costs. The short-term cost mainly comprises of budgets of promotion and
training. For promotion, email and posters can be used for informing doctors and nursing staffs
the new protocol. Additional costs for printing materials and other hardware (e.g. venue for
training and meetings, computer and software) are not needed since these are readily available
from the hospital. In terms of the long-term cost, the increment is equivalent to the difference in
the costs between povidone iodine and chlorhexidine. This is because, compared to the existing
protocol, the innovation only revise the antiseptic solution and skill of preoperative skin
preparation. From the information given by the pharmacy department of the hospital, the
povidone iodine that currently using costs $274.7 per 500ml whereas 2% chlorhexidine in 70%
alcohol costs $305 per 500ml.
Although chlorhexidine solution is slightly more expensive, it is proven to be more cost-
effective because of its greater power in reducing surgical site incidence rate. In a systematic
review, a net saving of $16–$26 (US dollars) per surgical case and $349,904 to $568,594 (US
dollars) per year were resulted after changing the use of povidone iodine to chlorhexidine (Lee et
al, 2010). Taking this as a reference, $675,552 - $1,097,772 (HK dollars) can be saved in six-
month period if the new protocol is implemented in th local setting. Detials of the estimated
saving is illustrated in Appendix V. There are other potential savings that may result from the
new protocol. First, staff are improved through participantion of the project. It is believed that all
staffs can learn from the project through interaction and cooperation. Their communication and
leadership skills can be improved. In addition, reduction of postoperaive surigcal site reduces
patient hosptital stay. Early evacuation of beds allows admission of new patient, resulting with
25
increased profit for the hosptial. Last but not least, Extra manpower is not necessary for handling
reopen cases which is reulted from posoperative surgical site infection.
3.2 Evidence-based Protocol
The evidence-based guideline of using chlorhexidine in preoperative skin preparation in
patients undergoing general surgery is presented in Appendix VI. The recommendations in the
protocol are based on the five studies reviewed in the previous chapter. One reviewed study has
high methodological quality (Darouiche et al., 2010); three with moderate methodological
quality (Berry et al., 1982; Brown et al, 1984; Sistla et al., 2010); and one with low quality
(Paocharoen et al., 2009). Each recommendation is carefully assessed by the grading system
developed by the Scottish Intercollegiate Guidelines Network (SIGNS, 2012) in order to show its
strength of current sustaining evidence.
26
CHAPTER 4
IMPLEMENTATION PLAN
4.1 Communication Plan
In the implementation of this innovation, different levels of stakeholders would be
affected by or might affect the proposed change. A comprehensive communication plan is
important for ensuring effective dissemination of the evidence-based protocol, improving
relationship and sharing ideas between stakeholders, reducing the risk of non-support and
uncooperativeness, and most importantly, ensuring goal achievement.
4.1.1 Identification of Stakeholders
Stakeholders who will involve in the protocol implementation are classified into three
levels, namely the administrative-, managerial-, and operational-level.
At the administrative level, the Department Operative Manager (DOM) and the consultant
of the surgical department are the top gatekeepers of this project. They have the highest authority
in capital and human resources allocation and the right to approve and terminate the project. The
managerial level consists of senior nurses assigned by the DOM and nursing officers (NOs).
They are responsible for resource coordination, promotion, staff training, supervising the process,
conducting pilot test, and providing continual evaluation on the new guideline. Since they are the
key stakeholders in the team, their experience and commitment are essential to the success of the
innovation. All frontline nursing staffs and surgeons are the stakeholders at operational level as
27
they are the users of the new guideline. The significance of the project outcome is greatly
depended on their understanding and cooperativeness. In addition, the Pharmacy Department
also takes part in the guideline change. They have to be informed with the consumption of the
new antiseptic solution, so they can ensure sufficient stocking in the hospital.
4.1.2 Communication Process and Strategies
Communication plays an important role throughout the entire process. Comprehensive
communication planning ensures effective transfer of ideas and positively impacts the innovation
outcomes. A timeline table corresponding to the communication process between stakeholders
throughout the different phases of the project is illustrated in Appendix VII.
To start with, the administrative stakeholders shall first be informed because they possess
the highest authority in the department. The DOM and consultant, who are the administrative
stakeholders, will be introduced to the significance of the clinical problem and the current
evidence on the innovation in one-week time. They will be informed of the potential
improvement in regards to the existing system and the patient outcomes. After obtaining their
verbal approval, the DOM will be invited to be the director of this project. The next step is to
establish a project team which will involve members with delegation and advanced experience.
The team members would include three project leaders (assigned by the DOM) and six project
coordinators (selected by the NOs from each team). An information talk will be launched to
inform all members the significance of the project and convince them to participate in this
constructive event.
28
In the next three weeks, the project team will work together to plan and organize
promotion, staff training and resources arrangement. In weeks 5 and 6, promotion and staff
training will be conducted by the project coordinators in group meetings for informing all
nursing staffs, preparing them for the new guideline on preoperative skin preparation.
In week 7, all operational stakeholders are supposed to be familiar with the new technique,
and then a pilot test will be started. A review will be done in 2 weeks after the pilot test to
identify any possible hinders during the guideline implementation and any improvement for
better outcomes. After all mentioned procedures, the refined guideline will be implemented.
Continuous evaluation on patient, staff and system outcomes will be done during implementation
period to evaluate the short-term, intermediate and long-term effect of the guideline.
4.2 Pilot Study Plan
4.2.1 Objectives
Before actual implementation of the new guideline, a pilot test will be conducted to detect
potential problems and determine feasibility (Polit & Beck, 2006).
4.2.2 Target Setting and Population
We shall target on adult surgical patients who will undergo open general surgeries. The
selecetion criteria will be the same as set out in the clinical guideline. From Monday to Saturday,
there are approximately eighteen open general surgeries performed in the local department each
29
day. The project leaders will be responsible to screen for the eligibles based on the inclusion and
exclusion criteria.
4.2.3 Time Frame
After the promotion and training programs for all nursing staffs and surgeons, the pilot test
will be launched from week 7 to 12 (see Appendix I). Taking current evidence as a reference,
significant results may appear approximately in 30 days after (Berry et al., 1982; Brown et al,
1984; Darouiche et al., 2010; Paocharoen et al., 2009; Sistla et al., 2010). The pilot
implementation of the proposed guideline will be done in the first 4 weeks and all relevant data
will be collected. Within the time frame, probably four hundred susceptible cases will be
recruited. In week 11 and 12, project leader will perform data analysis, prepare report of result
finding, and refine the guidelines.
4.2.4 Outcomes Measures
Outcome measures in the pilot study are postoperative surgical site infection rate and
bacterial colonization. In addition, staff acceptance, satisfaction and compliance to the new
guideline are also measured.
4.2.5 Data Collection
Team coordinators will be responsible for data collection. The runner of each surgery will
help photocopying the perioperative, anesthetic and operation records after each surgery. These
records include all necessary data such as patient demographic information, underlying disease,
30
length of preoperative stay, preoperational condition (ASA score, American Society of
Anesthesiologists pre-operative physical status assessment score), and information about the
operation. In addition, scrub nurse in each operation will record the type of preoperative skin
antiseptic solution and technique of preoperative skin preparation. Team coordinators will collect
the necessary information from the perioperative record and operation record and document it
with a data collection sheet (appendix VIII). Whenever possible, team coordinators will do onsite
observation during surgery to assess skin preparation techniques of the nursing staff, in order to
measure competence and compliance of the participants. According to the hospital guideline, the
infection control team will follow postoperative patients for 30 days for observing their surgical
wound. Therefore, apart from the follow-up record from surgeons, outcome measures including
date of surgical site infection development, signs and symptoms, grade of infection, causative
pathogens, prolonged hospital stay and other complication associated with the antiseptic solution
will also be gathered from data bank of the infection control team
4.2.6 Analysis and Evaluation of the Pilot Test Results
The result of the pilot study will be computerized and analyzed by the project leaders in
weeks 11 and 12. Apart from the study result, any problem or difficulty encountered during the
process will be documented in the report. Possible solution and recommendation will be
discussed in the project team meeting for compiling a more comprehensive plan in actual
implementation. The proposed guideline will be refined and submitted to the administrative level
for final approval by the end of week 12.
31
4.3 Evaluation Plan
4.3.1 Outcomes
In the actual implementation of the proposed guideline, different outcomes will be
measured in the evaluation plan. These outcomes are categorized into three classes including
patient outcomes, healthcare provider outcomes, and the system outcomes.
Patient outcomes are the rate of surgical site infection, time to infection, grade of infection
including superficial, deep, organ space and sepsis, pathogen isolated and its level in patient
serum, complications related to the infection and the length of prolonged hospital stay. Since the
goal of the guideline is to reduce the rate of postoperative surgical site infection, it is taken as the
primary outcome.
Since the effectiveness greatly depends on the cooperation of the actual users, frontline
nurses and surgeons, their compliance and satisfaction towards the new guideline are important
outcomes to be considered. In addition, all nurses are given new information and skill training in
the pilot test. Therefore, staff knowledge on the new evidence about preoperative skin
preparation, as well as their competence on performing proper skin preparation will also be
evaluated.
For system outcomes, cost and benefits will be compared and evaluated. Costs include
nursing manpower and expense of setting up and implementing the new guideline. Benefits, on
the other hand, are the reduction in hospital stay, improvement in quality of patient care, reduced
32
cost from extra medical or surgical treatment for complications resulted from postoperative
wound infection.
4.3.2 Nature of Subjects
In order to maintain consistency and homogeneity, characteristics of target subjects are
adult surgical patients over 18 year-old who are undergoing general open operations. This
selection criteria is derived from the current evidence based on the reviewed studies during the
process of proposal formation. There is no restriction on patients’ demographic characteristics,
ethnicity, current general condition, medical or surgical history and level of education. In
addition, recruited targets are irrespective of their types of anesthesia or organs involved in the
surgery.
4.3.3 Sample Size
Sample size is calculated by a free online statistical program (Lenth, 2010). In the
calculation of sample size for one proportion, “null value” and “actual value” are required. “Null
value” refers to current surgical site infection rate in the local setting whereas “actual value”
refers to surgical site infection rate after implementation of the proposed guideline. In the local
setting, overall infection rate is about 3.1% to 7% in 2011, depending on types (Infection control
team, 2011). From the reviewed literature, one study of high methodological quality (Darouiche
et al., 2010) reported 6.6% decrease in surgical site infection rate after the use of chlorhexidine.
Taking this as the expected decrease in surgical site infection rate after implementation of the
33
proposed guideline and 6% as the current surgical site infection rate in the local setting, a sample
size of 513 will be required to achieve a 5% statistical significance and 80% power for z-test.
4.3.4 Timing and Frequency of Outcomes Measurement
Timing and frequency varies according to different outcomes (see Appendix II). For
patient outcome, data collection is carried out in the perioperative and postoperative stage. At the
perioperative stage, data including patient’s demographics, operation information, and details of
skin preparation will be recorded. At the postoperative stage, patients will be followed by the
infection control nurse for 30 days for measuring other outcomes (e.g. patient condition, surgical
site infection, and length of hospital stay). A seasonal report will be prepared on a 3-month basis
in order to identify any necessary modification for the guideline implementation. For staff
outcomes, both short-term and long-term outcome measurement will be performed. After
promotional activity and training are given to all nursing staffs and surgeons (week 6),
questionnaires will be used to evaluate short-term outcomes including staff knowledge and
satisfaction towards these activities (see Appendix IX). In addition, this short-term measurement
also serves as the pretest for later long-term measurement. After one-year implementation, staff
knowledge and their satisfaction will be measured again as the posttest result. At the same time,
other staff outcomes such as their compliance, competence and satisfaction to the new guideline
will be measured for evaluating the long-term effect of the guideline. To evaluate cost-
effectiveness of the proposed guideline, system outcomes are under long term measurement.
Costs and benefits will be measured one year after the implementation.
34
4.3.5 Analysis of Data
The collected data will be verified and then analyzed by project leaders in one-month time.
Patient demographics and their medical or surgical conditions will be summarized by descriptive
statistics. At the stage of guideline formation, the conservative estimate of the surgical site
infection is 7%. In order to determine the rate changed since the implementation of the proposed
guideline, two-tailed z-test for testing one proportion will be used. Staff outcomes such as staffs’
knowledge, compliance, competence, and satisfaction will also be summarized using descriptive
statistics and the 95% confidence intervals will be reported. A 5% level of significance will be
used in all statistical tests. Qualitative data such as reason for non-compliance and comments
from staffs require further elaboration by project leader, so a more comprehensive analysis with
constructive suggestion can be used for later refinement of the guideline. For cost-effectiveness
analysis, costs saved related to the reduced surgical site infection will be compared with the
expense resulting from manpower, material, equipment, staff training and promotion. After data
analysis, results and suggested improvement will be reported in a written format and presented to
project directors.
4.3.6 Criteria for Determining Guideline Effectiveness
The proposed guideline is considered to be effective if the following criteria are reached.
Firstly, the rate of postoperative surgical site infection is expected to be decreased after the
implementation of proposed guideline. All of the previously reviewed studies reported positive
impact on surgical site infection after the use of chlorhexidine gluconate in preoperative skin
preparation. However, their results are different and the decrease in surgical site infection rate
ranged from 1.5% to 6.6% (Darouiche et al., 2010; Paocharoen et al, 2009; Berry et al., 1982;
35
Brown et al., 1984; Prabhu et al., 2010). For the proposed guideline, the effective reduction rate
in surgical site infection is set to be at least 1.5%. Secondly, for an effective guideline, a positive
change in staff compliance, confidence, and satisfaction on preoperative skin preparation are
expected. The compliance of the new practice is expected to be over 95%. In addition, 80%
increase in staff knowledge and 70% increase in satisfaction are expected in the pretest and
posttest evaluation. Lastly, concerning system outcome, final cost of this proposed guideline
should not exceed $109, 661, which is the estimate reported in chapter 3 (see Appendix IV). At
the same time, at least $675,552 (HK dollars) should be saved after the implementation of the
new protocol in the local setting (see Appendix V).
36
1
Appendix I. Evidence Table
Bibliog Study Evidenc Application Length of Effect size
raphic Patient characteristics Intervention Comparison Outcome measures
citation type e level Method follow up (Intervention - Control)
Daro RCT 1++ General surgery 2% CH in 10% PVI Scrub then 30 days Primary Primary
uiche 70% IA (n=422) paint 1) SSI (case) 1) -0.066 (P=0.004)
, et I group C group (n=391) Secondary Secondary
al., Age/yr 53.3 52.9 2) Grade of infection (case) 2) a) -0.044 (P=0.008)
2010 +14.6 +14.2 a) Superficial b) -0.120 (P=0.04)
Female 91 122 b) Deep c) -0.0014 (P=0.919)
Male/% 58.9 55.9 c) Organ/ space d) -0.016 (p=0.199)
OT/hrs 3.0±1.5 3.0±1.5 d) Sepsis
Berry RCT 1+ General surgery 0.5% CH in 10% PVI in Paint 3-4 days Primary Primary
et al., sprit alcohol 1) SSI (case) 1) -0.005 (P=0.011)
1982 Age(median)/yr: 45-64 (n=453) (n=413) Secondary Secondary
2) Significant bacterial growth 2) -0.01 (P=0.22)
(case)
Brow RCT 1+ General surgery 0.5% CH in 10% PVI 6 mins PVI Not Primary Primary
n et 70% IA (n=359) soap scrub mention 1) SSI (case) 1) -0.05 (P=0.01)
al, Age > 18 spray then dried, Secondary Secondary
1984 (n=378) then PVI 2) Grade of infection (case) 2) a) -0.10 (P=0.120)
paint or a) Separation b) -0.01 (P=0.044)
CHG spray b) Hematoma/ Seroma
Sistla RCT 1+ Hernia 2.5% CH in 10% PVI Paint then 30 days Primary Primary
, et 70% IA (n=200) allow to dry 1) Reduction in BC (×102 CFU)
al., I group C group (n=200) a) Overall 1) a) -22.86 (P=0.787)
2010 Age ≤ 60 157 149 b) Infected b) -45.4 (P=0.507)
> 60 43 51 c) Non-infected c) -11.35 (P=0.402)
Female 7 2 2) SSI (case) 2) -0.025 (P=0.364)
Male 193 198 Secondary Secondary
OT<55min 159 161 3) BC (×102 CFU) 3) a) -6.32 (P=0.085)
>55min 41 39 a) Before b) -1.41 (P=0.053)
b) After
4) Postop BC: preop hospital 4) -53.88 (P=0.001)
stay to ≤48 to >48 hrs (×102
CFU)
5) Grade of SSI (case) 5) a) -0.01 (P=0.558)
a) Grade 1 b) -0.01 (P=0.630)
b) Grade 2 c) -0.005 (P=0.562)
c) Grade 3
Paoc RCT 1- General surgery 4% CH in PVI 5 mins scrub 1 mth Primary Primary
haroe 70% IA (n=250) 5 mins paint 1) Postop BC >103CFU/ml 1) -0.168 (P<0.0002)
n, et I group C group (n=250) (case) 2) -0.012 (P=0.399)
al., Age/yr 50.5 56.2 2) SSI (case) Secondary
2009 (18-78) (20-79) Secondary 3 a) -0.108 (P=0.0009)
Female 91 122 3) BC >103CFU/ml (case)
Male 159 138 a) S.epidermidis b) -0.016 (P=0.201)
OT/hrs 1.45 1.43 b) S.aureus c) -0.044 (P=0.024)
c) Streptococcus sp. d)-0.004 (P=0.316)
d) Enterococcus sp.
4) Allergy reaction (case) 4) 2 cases in PVI group
RCT= Randomized control trail, I= Intervention, C= Control, OT = Operation time, CH=Chlorhexdine, IA = Isopropyl alcohol, PVI = Povidone–iodine, BC= Bacterial colonization, CFU=Colony-forming units (CFU)/ml
SSI= Surgical site infection, P=P value
37
SIGNS Methodology Checklist
Appendix II.SIGNS
MethodologyChecklist
ethodologyChecklist 2: Controlled Trials
SIGN
Study identification (Include

Include author, title, year of publication, journal title, pages)
Guideline topic: Key Question No:
Before completing this checklist, consider:

1. Is the paper a randomized controlled trial or a controlled clinical trial?? If in doubt, check
the study design algorithm available from SIGN and make sure you have the correct checklist. If
it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study
cannot be rated higher than 1+
2. Is the paper relevant
elevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: Reason for rejection: 1. Paper not relevant to key question □ 2. Other reason □
(please specify):
Checklist completed by:
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… In this study this criterion is:
1.1 The study addresses an appropriate and clearly Well covered Not addressed
focused question. Adequately addressed Not reported
Poorly addressed Not applicable
1.2 The assignment of subjects to treatment groups Well covered Not addressed
is randomised Adequately addressed Not reported
1.3 An adequate concealment method is used Well covered Not addressed

Adequately addressed Not reported
1.4 Subjects and investigators are kept ‘blind’ about Well covered Not addressed
treatment allocation Adequately addressed Not reported
1.5 The treatment and control groups are similar at Well covered Not addressed
the start of the trial Adequately addressed Not reported
38
1.6 The only difference between groups is the Well covered Not addressed
treatment under investigation Adequately addressed Not reported
1.7 All relevant outcomes are measured in a Well covered Not addressed
standard, valid and reliable way Adequately addressed Not reported
1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study
dropped out before the study was completed?
1.9 All the subjects are analysed in the groups to Well covered Not addressed
which they were randomly allocated (often Adequately addressed Not reported
referred to as intention to treat analysis)
1.1 Where the study is carried out at more than one Well covered Not addressed
0 site, results are comparable for all sites Adequately addressed Not reported
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias?

Code ++, +, or 
2.2 Taking into account clinical considerations,
your evaluation of the methodology used, and
the statistical power of the study, are you
certain that the overall effect is due to the study
intervention?
2.3 Are the results of this study directly applicable
to the patient group targeted by this guideline?
2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the
study, and the extent to which it answers your question.
39
Appendix III.SIGNS Level of Evidence
Level of Evidence (Scottish Intercollegiate Guidelines Network, 2011)

Level of
Descriptions
evidence
High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low
1++
risk of bias
Well conducted meta-analyses, systematic reviews, or RCTs with a low risk of

1+
bias
1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias
High quality systematic reviews of case control or cohort studies

2++ High quality case control or cohort studies with a very low risk of confounding or
bias and a high probability that the relationship is causal
Well conducted case control or cohort studies with a low risk of confounding or
2+
bias and a moderate probability that the relationship is causal
Case control or cohort studies with a high risk of confounding or bias and a
2-
significant risk that the relationship is not causal
3 Non-analytic studies, e.g. case report, case series
4 Expert opinion
40
Quality assessment for individual study
Appendix IV.Quality
SIGN

Include author, title, year of publication, journal title, pages
pages)
AlSharif, A., Awad, S.S., Berger, D.H., Carrick, M.M., Crosby, C.T., Darouiche, R.O., Itani, K.M.F.,
Miller, H.J., Mosier, M.C., Otterson, M.F., Wall, M.J., Webb, A.L. Chlorhexidine
Chlorhexidine–Alcohol
Alcohol versus
Povidone-Iodine for Surgical-Site
Site Antisepsis N Engl J Med 2010;362:18
2010;362:18-26

3. Is the paper a randomized controlled trial or a controlled clinical trial?? If in doubt,
check the study design algorithm available from SIGN and make sure you have the correct
checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and
a
the study cannot be rated higher than 1+
4. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Reason for rejection: Reason forr rejection: 1. Paper not relevant to key question □ 2. Other reason
□ (please specify):
1.1 The study addresses an appropriate and Well covered.

clearly focused question. The aim of the study was clearly stated in
introduction.
1.2 The assignment of subjects to treatment Well covered.
groups is randomised Randomization was stratified by hospital with the
use of computer-generated
generated randomization
1.3 An adequate concealment method is used Adequately addressed.

Centralized allocation by hospital was used.
1.4 Subjects and investigators are kept ‘blind’ Well covered.

about treatment allocation Both the patients and the site investigators who
diagnosed surgical site infection remained unaware
of the group assignment.
1.5 The treatment and control groups are similar at Well covered.
the start of the trial Patients in two study groups were similar with
respect to demography characteristics, coexisting
illness, risk factors for infection, antimicrobial
exposure, duration, type of surgery.
41
1.6 The only difference between groups is the Well covered.
treatment under investigation The only difference between the groups was the
preoperative skin antiseptic preparation which is the
intervention under study.
1.7 All relevant outcomes are measured in a Adequately addressed.
standard, valid and reliable way The diagnosed of surgical site infection was on the
basis of criteria developed by CDC.
The wounds were assessed by same investigation
1.8 What percentage of the individuals or clusters Intervention group: 2
recruited into each treatment arm of the study Control group: 2
1.9 All the subjects are analysed in the groups to Well covered.
which they were randomly allocated (often Intention to treat was used in the study.
1.1 Where the study is carried out at more than Well covered.
0 one site, results are comparable for all sites Results were comparable.. To determine whether
the results were consistent across the 6 participating
hospitals, a prespecified Breslow-Day test for
homogeneity was performed.
2.1 How well was the study done to minimise bias? 1++
Code ++, +, or  Adequate blinding, concealment, similar group
characteristics, intention-to-treat, multiple sites.
2.2 Taking into account clinical considerations, your Yes.

evaluation of the methodology used, and the This study was conducted in a systematic manner.
statistical power of the study, are you certain It was of high methodological quality.
that the overall effect is due to the study
intervention?
2.3 Are the results of this study directly applicable Yes.
to the patient group targeted by this guideline?
- The application of chlorhexidine-alcohol reduced the risk of surgical site infection by 41% as
compared with povidone-iodine.
- The effect of povidone-iodine and chlorhexidine-ethanol in the reduction of bacterial counts was not
significantly different (59.14 vs. 82%; p = 0.78).
- The superior clinical protection provided by chlorhexidine-alcohol is probably related to its more
rapid action, persistent activity despite exposure to bodily fluids, and residual effect.
- Although the use of flammable alcohol-based products in the operating room poses the risk, though
small, of fire or chemical skin burn, no such adverse events occurred in this study or the other studies.
- The overall superior protection afforded by chlorhexidine-alcohol was attributed primarily to a
reduction in the rates of superficial and deep incisional infections that were caused mostly by gram-
positive skin flora.
42
SIGN

pages)
Berry, A. R., Goldacre, M.J., McNair, T.J., Thomson, J.W., & Watt, B. (1982). A comparison of the
use of povidone-iodine
iodine and chlorhexidine in the prophylaxis of postoperative wound infection. Journal
of Hospital Infection., 3(1): 55-63.
63.

6. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES com complete
plete the checklist.
Reason for rejection: Reason for rejection: 1. Paper not relevant to key question □ 2. Other reason
1.1 The study addresses an appropriate and clearly Well covered.

focused question. The aim of study was clearly stated in the
introduction.
1.2 The assignment of subjects to treatment groups Adequately addressed.
is randomised Randomization was done by a table of random
numbers.

The authors described that the sequence of
randomization was known only to one of the
researchers. The result of randomization was
recorded on a card and each card was put in a
sealed envelope.
1.4 Subjects and investigators are kept ‘blind’ about Not addressed.
treatment allocation It was beyond the scope of the study to arrange
for observations on patient’s wounds to be made
totally blind.
1.5 The treatment and control groups are similar at Poorly addressed.
the start of the trial Age, sex and operation nature were compared
without statistical analysis. Insufficient data to
prove the similarity between groups.
1.6 The only difference between groups is the Adequately addressed.
treatment under investigation The only difference between
ween the groups was the
preoperative skin antiseptic preparation which is
the intervention under study.
43
1.7 All relevant outcomes are measured in a Adequately addressed.
standard, valid and reliable way Wounds were agreed by 2 observers, one
member of nursing staff and one member of
medical staff. The observation and
documentation were taken in a standard format.
Swabs were also taken for microbiological test.
1.8 What percentage of the individuals or clusters Not mentioned.
recruited into each treatment arm of the study
1.9 All the subjects are analysed in the groups to Not addressed.
which they were randomly allocated (often Intention-to-treat analysis was not mentioned.
1.1 Where the study is carried out at more than one Not applicable.
0 site, results are comparable for all sites Study was conducted at a single site.
2.1 1+
How well was the study done to minimise bias?
The fact that several surgeons participated I the
Code ++, +, or  study, several observers were responsible for
recording wound observations, and each set of
observations was made by two observers, all
allowed serious bias to be avoided.
evaluation of the methodology used, and the
statistical power of the study, are you certain that
the overall effect is due to the study intervention?
2.3 Are the results of this study directly applicable to No.

the patient group targeted by this guideline?
- Wound infection after bililary tract and clean non-abdominal operations was significantly less
common among patients prepared with chlohexidine than those prepared with povidone iodine.
- However, for abdominial operations other than those of the biliart tract, wounf infections were less
common among patients prepared with povidone iodine than with chlohexidine.
44
SIGN

pages)
Brown, T. R., Ehrlich, C.E., Eitzen, H.E.,Golichowski, A.M., Madura, J.A., & Stehman, F.B. (1984). A
clinical evaluation of chlorhexidine gluconate spray as compared with iodophor scrub for preoperative
skin preparation. Surg Gynecol Obstet, 158(4):363
158(4):363-6.


introduction.
1.2 The assignment of subjects to treatment groups is Adequately addressed.
randomised Patients were randomized by stratified
randomization.

Seal envelopes were used.
treatment allocation Blinding method was not mentioned in
the study, indicating that this aspect of
study design was ignored.
1.5 The treatment and control groups are similar at the Well covered.
start of the trial No significant differences between the
patients in two groups when analyzed for
demographic fators, preoperative
conditions, coexisting health problems,
hemoglobin concentration, or white
wh blood
cell counts or prior radiation therapy.
1.6 The only difference between groups is the treatment Adequately addressed.
under investigation Use of systemic antibiotic might be
different as it was determined by the
operating surgeons.
45
1.7 All relevant outcomes are measured in a standard, Adequately addressed.
valid and reliable way The infected wounds were inspected by
one author to confirm the finding
recorded by the surgeon of the patient.
Cultures were obtained to the
microbiology laboratory for qualitative
analysis.
1.8 What percentage of the individuals or clusters recruited 0%
into each treatment arm of the study dropped out
before the study was completed?
1.9 All the subjects are analysed in the groups to which Adequately addressed.
they were randomly allocated (often referred to as 100% of the patients had completed in-
intention to treat analysis) hospital follow-up study
1.10 Where the study is carried out at more than one site, Adequately addressed.
results are comparable for all sites The study results were comparable for the
two hospitals.
2.1 How well was the study done to minimise bias? 1+

Code ++, +, or  There was a bias with regards to
preoperative chemotherapy. The authors
did a separate analysis of these patients
and revealed that they did not contribute
to excess morbidity or affect the overall
outcome. So this imbalance did it affect
the validity of the result.
evaluation of the methodology used, and the statistical This study was conducted in a systematic
power of the study, are you certain that the overall manner. It was of high methodological
effect is due to the study intervention? quality.
2.3 Are the results of this study directly applicable to the Yes.
patient group targeted by this guideline?
- The wound infection rate in the two groups was not statistically different.
- The spray technique is more convenient and reduces operating room time and anesthesia time from
10 minutes to 30 seconds. This time saving might be crucial to the patient in centein emergency
situations such as fetal distress, trauma or ruptured abdominial aortic aneurysm. It is also cost saving
and efficient.
- The total cost savinfs per year is significant. The cost is $0.85 per patient for provodone iodine
solution whereas $0.07 for chlorhexidine spray.
46
SIGN

pages)
Prabhu, G., Sadasivan., J., Sistla, S., Sistla, S.C. (2010). Minimizing Wound Contamination in a
‘Clean’Surgery: Comparison of Chlorhexidine
Chlorhexidine-Ethanol and Povidone-Iodine.
Iodine. Chemotherapy, 56:261–
56:261
267.


focused question. The aim of the study was clearly stated in
introduction.
1.2 The assignment of subjects to treatment groups is Not addressed.
randomised The detail of the randomization process
not mentioned.
Sealed envelope method was mentioned.
1.4 Subjects and investigators are kept ‘blind’ about Well covered.
treatment allocation Concealment to the surgeons was not
possible due to the difference in the
physical characteristics of the antiseptics.
Information regarding the antiseptic used
was not available to the investigators or
patients during assessment of surgical site
infection.
1.5 The treatment and control groups are similar at the Adequately addressed.
start of the trial The patient characteristics
cteristics in both the
groups were similar.
Influence of patient and procedure
variables on surgical site infection was
under univariate analysis.
47
under investigation The only difference between the groups
was the preoperative skin antiseptic
preparation which is the intervention
under study.
1.7 All relevant outcomes are measured in a standard, Adequately addressed.
valid and reliable way The diagnosed of surgical site infection
was on the basis of criteria developed by
CDC.
The assessment was done by patient self-
report questionnaire
Specimens collected to laboratory
analysis.
1.8 What percentage of the individuals or clusters recruited Adequately addressed.
into each treatment arm of the study dropped out Not more than 5%.
1.9 All the subjects are analysed in the groups to which Not addressed.
they were randomly allocated (often referred to as Intention-to-treat analysis was not
intention to treat analysis) mentioned.
1.10 Where the study is carried out at more than one site, Not applicable.
results are comparable for all sites
2.1 1+
Quantitative cultures were performed in
Code ++, +, or 
only a limited number of patients as a
postal questionnaire was used for post-
discharge surveillance.
Although intention-to treat were not
observed, the effect of 5% missing values
was relative small.
evaluation of the methodology used, and the statistical Despite of the above potential limitations,
power of the study, are you certain that the overall the study was conducted in a systematic
effect is due to the study intervention? manner.
- The difference in the incidence of infection between povidone-iodine, 9.5% (19/ 200), and
chlorhexidine ethanol, 7.0% (14/200), was not significant (p = 0.364).
- The effect of povidone-iodine and chlorhexidine-ethanol in the reduction of bacterial counts was not
significantly different (59.14 vs. 82%, p = 0.78).
- Univariate analysis found bilateralism, duration of preoperative stay and duration of surgery (>48hrs)
to be significant risk factors for SSI.
- We observed that the skin bacterial count increased with a longer preoperative stay and the incidence
of wound infection was 12.7% in patients with more than 48 h of preoperative hospital stay compared
with 5.6% in those with shorter preoperative hospital stay (p = 0.01).
- In this study, there was significantly more infection in patients in whom the surgical procedure
exceeded 55 min (75th percentile time for this study group) (13.7 vs. 6.9%, p = 0.046).
48
- The most common organisms isolated from infected wounds of these patients were Staphylococcus
aureus and S. epidermidis.
SIGN

pages)
Apisarnthanarak., A., Mingmalairak, C., Paocharoen , V. Comparison of Surgical Wound Infection
after Preoperative Skin Preparation with 4% Chlohexidine and Povidone Iodine: A Prospective
Randomized Trial J Med Assoc Thai 2009; 92 (7): 898
898-902


introduction.
1.2 The assignment of subjects to treatment groups is Not reported.

randomised Detail of randomization method was not
reported, insufficient detail to allow
assessment to be made
1.3 An adequate concealment method is used Not addressed.
Not mentioned in the study, indicating
that this aspect of study design was
ignored.
treatment allocation Blinding method was not mentioned in
the study, indicating that this aspect of
study design was ignored.
49
1.5 The treatment and control groups are similar at the Adequately addressed.
start of the trial There was no significant statistical
difference of the risk factors between two
groups such as age, operative time, would
classification, or underlying host factors.
under investigation The author allowed other preoperative
preparation under the standard guidelines.
The only difference between the groups
was the preoperative skin antiseptic
preparation which is the intervention
under study.
1.7 All relevant outcomes are measured in a standard, Adequate addressed.
valid and reliable way An incisional surgical site infection had
occurred if a surgical wound drained
purulent materials or if the surgeon judges
it to be infected and open it.
Specimens collected to laboratory
analysis.
1.8 What percentage of the individuals or clusters recruited Not mentioned.
into each treatment arm of the study dropped out
1.9 All the subjects are analysed in the groups to which Not addressed.
they were randomly allocated (often referred to as Intention-to-treat analysis was not
intention to treat analysis) mentioned.
1.10 Where the study is carried out at more than one site, Not applicable.
results are comparable for all sites Study was conducted at a single site.
2.1 1-
Methods of randomization, blinding,
Code ++, +, or  concealment and intention-to-treat were
not mentioned in the study.
2.2 Taking into account clinical considerations, your No.
evaluation of the methodology used, and the statistical Given the above potential biases, study
power of the study, are you certain that the overall results could not be solely attributed to
effect is due to the study intervention? study intervention.
- The authors demonstrated that pharmacologic action against gram-positive organism of
chlorhexidine might be superior to povidone iodine. Wound infection could be decreased
from 3.2% to 2% after chlorhexidine skin preparation.
- However, chlorhexidine skin preparation could not totally prevent infection caused by gram-
negative bacilli or anaerobic organism such as Enterobacter in appendectomy and
gastrectomy.
- Color staining and hypersensitivity are another disadvantage of povidone iodine solution.
50
Appendix V.Estimated set up cost of the new guideline
Estimated set up cost of the new guideline (6-month-period)

Manpower Cost
Items Item Dscription Item Cost Total Cost
Project director Department manger Salary: $312/hour
2 meetings with project coordinators $312 x 2 hrs x 2 = $1248
Final evalaution and approval $312 x 2 hrs x 1 = $624 $1,872
3 Project leaders Senior nursing staffs Salary: $238/hour
3 meeting with project director $238 x 3 x 2 hrs x 3 times =$4284
3 meeting with project committee $238 x 3 x 2 hrs x 3 times =$4284
1 informative talk to project committee $238 x 3 x 2 hrs x 1 time =$1428
Data analysis and evaluation $238 x 3 x 2 hrs x 1 time =$1428 $11,424
6 Project Moderalty senior nursing staff Salary: 214/hour
coordinator 3 meeting with project leader $214 x 6 x 2 hrs x 3 times = $7704
1 informative talk $214 x 6 x 1 hrs x 1 times = $1284
1 training session to group members $214 x 6 x 1hrs x 1 times = $1284 $10,272
91 Nursing staff All other nursing staffs Salary: $142/hour
1 training sesseion $214 x 91 x 1 hrs x 1 time = $19474 $19,747
Subtotal estimated cost (HKD): $43,315
Material Cost
Items Item Dscription Item Cost Total Cost
Equipment Cost of 2% chlorhexidine in 70% Extra cost required: $30.6
alcohol solution = $305/500ml $30.6 x 360/month x 6
Cost of povidone iodine solution
=$274.7/500ml $66,096
Staff Training Photocopying & Printing cost Hospial provision
Venue & equipments Hospial provision
Computers and computer software Hospial provision
Promotion Email Hospial provision $0
5 posters $50 x 5 $250
Subtotal estimated cost (HKD): $66346
Total estimated cost (HKD): $ 109,661
51
Appendix VI. Estimated saving from the new guideline
Estimated saving from the new guideline (6-month-period)

Healthcare saving
Items Item Dscription Item saving
Reduced surgical site infection Saving/surgical case: $16–$26(USD)
No. of surigcal cases/month: 1440
(Lee et al, 2010)
Open surgery: 65%
Rate: $1USD=$7.75HKD (9/12/2012)
Adult patients: 97%
No. of taget population/month:
$16 x $7.75 x 908 x 6mth = $675,552
1440 x 65% x 97% = 908
$26 x $7.75 x 908 x 6mth = $1,097,772
Subtotal estimated cost (HKD): $675,552 - $1,097,772
Potential hidden saving
Items Item Dscription Item Saving
Evacuation of beds Reduction of postoperaive surigcal Not estimated
site reduces patient hosptital stay.
Free beds can be reserved for new
patient admission.
Decreased extra-manpower Extra manpower is not necessary Not estimated
for handling reopen cases which is
reulted from posoperative surgical
site infection.
Staff training for higher Staffs are trained by direct Not estimated
standard interraction and cooperation,
effective communication and
leadership skills can be enhanced.
Promotion and advertisment Implementation of evidence-based Not estimated
protocol raises the nursing care of
the hospital, which in turn help the
building up of hospital image.
Total estimated cost (HKD): $675,552 - $1,097,772
52
Appendix VII. The evidence-based guideline
An Evidence-based Protocol:
Using 2%chlorhexidine in 7-% alcohol in preoperative skin

preparation to reduce surgical site infection in adult patients
undergoing general surgery
1st Edition on 8 December 2012 by Erica Lai (RN)
I. INTRODUCTION
Background
The Centers for Disease Control and Prevention reported that surgical site infections
made up 14% to 16% of all infections and it is the third most frequently reported hospital-
acquired infection worldwide (Centers for Disease Control and Prevention, 2009).
Surgical site infection not only brings morbidity and mortality to patients, but also
substantial financial burden to the hospital and the whole healthcare system.
Perioperative nurse plays an important role in minimizing the incidence of surgical
site infection by rigorous adherence to aseptic techniques and also fast response to the
most updated evidence-based practice. In recent year, extensive studies have investigated
chlorhexidine on its stronger antiseptic power over povidone iodine (Munoz-Price et al,
2012).In view of this, it is an inevitable need to develop an evidence-based protocol of
preoperative skin preparation by chlorhexidine in order to reduce the incidence of
postoperative surgical site infection.
Aim
The aimof the protocol is to summarize the best available evidence concerning the
use of chlorhexidine in preoperative skin preparation. The recommendations developed
serve as guidelinein clinical practice to reduce the incidence of surgical site infection in
patients undergoing general open surgery.
53
Intended users
 Hospitals
 Operating department
 Surgeons
 Theater nurses
 Operation assistant
Target Population
 Adult surgical patients over 18 year-old undergoing general open operations
II. METHODOLOGY
For identification of studies, electronic databases including Medline, PubMed and

CINHAL were systematically searched in July 2012 with keywords “chlorhexidine Studies
were limited to human species, adults aged 18 or above and randomized control trial.”,
“povidone iodine” and “surgical wound infection”. There were totally 5 studies selected
finally, including 4 eligible studies yielded from the database search together with one from
manual search of the systematic review. All included studies were evaluated by a critical
appraisal tool established by the Scottish Intercollegiate Guidelines Network (SIGNS, 2012).
Among them, one study demonstrated high methodological quality (Darouiche et al., 2010),
three demonstrated moderate methodological quality (Berry et al., 1982; Brown et al, 1984;
Sistla et al., 2010) and only one study demonstrated low quality methodology (Paocharoen et
al., 2009).
The following recommendations are extracted from the critically reviewed studies.
Each recommendation is carefully assessed by the grading system developed by the Scottish
Intercollegiate Guidelines Network (SIGNS, 2012) in order to show its strength of supporting
evidence. However, it does not reflect the clinical importance of the recommendation.
54
III. RECOMMENDATION
Recommendation 1
Chlorhexidine-alcohol should be the first consideration for preoperative skin preparation.
Grade of recommendation: A
Evidence: All reviewed study reported reduced incidence of postoperative surgical site
infection was significantly lower in patients prepared with chlorhexidine than in those
prepared with povidone iodine preoperatively (Darouiche et al., 2010) [1++](Berry et al.,
1982; Brown et al, 1984; Sistla et al., 2010) [1+](Paocharoen et al., 2009)[1-].
Recommendation 2
Nursing assessment should be done on patient and surgical site before skin preparation.
Evidence: Before skin preparation, the surgical site should be assessed for any wound,
rash or other skin conditionwhich is high-risk area for colonization by microorganisms.
Patient history of allergy reaction should also be checked. If patient had previous
experience of chlorhexidine or alcohol hypersensitivity, other choice of antiseptic solution
may have to consider(Darouiche et al., 2010) [1++]. In addition, if hair removal is
required, it should be done just before surgery in the operating theater as this is associated
with lower risk of surgical site infection (Sistla et al., 2010) [1+]
Recommendation 3
The application method of chlorhexidine-alcohol is simply painting for 2 times.
55
Evidence: The application method of antiseptic solution in preoperative skin preparation
varies among studies. Three of the reviewed studies used scrubbing followed by painting
(Darouiche et al., 2010)[1++](Brown et al, 1984)[1+] (Paocharoen et al., 2009)[1-],
whereas other two studies used simply painting (Berry et al., 1982; Sistla et al., 2010)
[1+]. However, the difference in postoperative surgical wound infection between the two
methods, painting and scrubbing followed by painting, is not significant (Sistla et al.,
2010) [1+]. The first painting is useful in removing the superficial soil and debris from the
skin whereas the second painting allows the removal of transient flora and microbes on
patient’s skin.Therefore, the usual skin preparation method in the local setting can still be
adopted. In a open gerenal surgery preoperatively, the abdomen should be painted with
chlorhexidine-alcohol starting from the incision site in a single uniform application.
Recommendation 4
Sufficient time should be allowed to let chlorhexidine-alcohol dry enough before draping.
Evidence: Although some suggested there might be fire hazard when using alcohol-based,
product, the reviewed studies stated that chlorhexidine-alcohol was safe to use since no
cases of chemical skin burn or fire hazard observed in the operating room in studies.
(Darouiche et al., 2010) [1++] The solution should be given adequate time to dry
completely before the application of surgical drapes in order to allow adequate time for
antimicrobial action of the antiseptic solution and allow complete evaporation of alcohol
to prevent sparkling during use of electrosurgical devices (Paocharoen et al., 2009)[1-].
56
Recommendation 5
Use of chlorhexidine-alcohol in spray form
Grade of recommendation: B
Evidence: A reviewed study suggested that the power of reducing skin bacterial counts of
chlorhexidine-alcohol in spray form was equally effective. In addition, The use of spray
technique is more convenient and it allows 30 seconds to 10 minutes saved. Thus, this is
especially important during emergency situation. (Brown et al, 1984) [1+]
57
IV. REFERENCES
Berry, A. R., Watt, B., Goldacre, M.J., Thomson, J.W., & McNair, T.J. (1982). A comparison
of the use of povidone-iodine and chlorhexidine in the prophylaxis of postoperative
wound infection. Journal of Hospital Infection, 3(1):55-63.
Brown, T. R., Ehrlich, C.E., Stehman, F.B., Golichowski, A.M., Madura, J.A., & Eitzen, H.E.
(1984). A clinical evaluation of chlorhexidine gluconate spray as compared with
iodophor scrub for preoperative skin preparation. A clinical evaluation of chlorhexidine
gluconate spray as compared with iodophor scrub for preoperative skin preparation.
Surgery Gynecology Obstetric, 158(4):363-6.
Darouiche, R.O., Wall, M.J., Itani, K.M.F., Otterson, M.F., Webb, A.L., Carrick, M.M.,
Miller, H.J., Awad, S.S., Crosby, C.T., Mosier, M.C., AlSharif, A., & Berger, D.H.
(2010). Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis.
New England Journal of Medicine, 362(1):18-26.
Paocharoen, V., Mingmalairak, C., & Apisarnthanarak, A. (2009). Comparison of surgical
wound infection after preoperative skin preparation with 4% chlorhexidine [correction
of chlohexidine] and povidone iodine: a prospective randomized trial. Journal of the
Medical Association of Thailand, 92(7):898-902.
SIGN. 2012. Evidence table for intervention studies. Retrieved Apr 30, 2012 from
http://www.sign.ac.uk/guidelines/fulltext/50/compevidence.html
Sistla, S.C., Prabhu, G., Sistla S., & Sadasivan J. (2010). Minimizing wound contamination in
a 'clean' surgery: comparison of chlorhexidine-ethanol and povidone-iodine. .
Chemotherapy, , 56(4):261-267.
58
Appendix VIII.Timeline and Communication Plan for preparation, pilot, implementation and evaluation
Weeks Month
Task / Description Organizer Targets 1 2 3 4 5 6 7 8 9 10 11 12 1---------------3 -----------------6 ---------------12
Project leader Department
*
Seek Approval
- State importance of problem operative manager
- Explain reason for change
Illustrate current evidence Surgical team head
- Present proposal
- Ask DOM to be project director
Project leader Department
*
Project Team Development
- Highlight significance of project operative manager
- 2 more project leaders assigned by DOM
- 6 project coordinator assigned by NOs Nursing officer
Project leaders Project coordinators
*
Informative Talk
PREPARATION
- Highlight significance of project

- Brief following tasks and duties
Project leader Project leaders &
* * *
Project Planning
- Develop promotion plan coordinators
- Design poster for promotion
- Plan training schedule
- Prepare training materials and notes
- Arrange resources and equipment
- Contact Pharmacy Dept. to order chlorhexidine
gluconate and reduce the order of betadine
- Division of work
Project leaders & Nursing staffs
*
Promotional Activity
- Announce the new guideline coordinators Surgeons
- Posters in OT rooms, tea rooms, open areas
- Promotion during group meetings
- Emails to surgeons
Project Nursing staffs
* *
Staff Training
- Present the significance of the new guideline coordinators
- Provide training to team members during
group meeting
Project leaders & Nursing staffs
* * * *
Pilot Test
- Collect feedback at the end coordinators Surgeons
PILOT
Project leaders Department

* *
Pilot Test Review
- Report pilot result operative manager
- Discuss findings from pilot study
- Share difficulties and challenges Project coordinators
- Identify possible solutions for the challenges
- Refine the guidelines
All nursing staffs Patients
IMPLEMENTATION Surgeons * * *
Patient outcomes Project Patients
- SSI, time to infection, grade of infection, coordinators
* * *
EVALUATION
pathogen and serum level, complications,

length of prolonged hospital stay.
Project All nursing staffs
* *
Staff outcomes
- Knowledge, satisfaction coordinators Surgeons
- Compliance, competence and satisfaction
System outcome Project leaders Hospital
-
-
Costs
Benfits
*
59
Appendix IX.Data collection sheet
Evidence-based guidelines for chlorhexidine gluconate Case Number:

in preoperative skin preparation to reduce surgical site
infection in patients undergoing general surgery
(Patient label)
Data collection sheet
PART I: DEMOGRAPHY INFORMATION
1. Gender / Age : M / F / Age:
2. Height / Body Weight : cm / kg
3. Underlying diseases :
4. Length of preoperative stay : days
5. ASA score : 1 / 2 / 3 / 4 / 5
PART II: PREIOPERATIVE INFORMATION

1. Preoperative diagnosis :
2. Date of operation :
3. Duration of operation : minutes
4. Type of operation :
5. Operating surgeons : (Chief) Dr. , (Assistant) Dr. , Dr.
6. Emergency / elective : Emergency / Elective
7. Use of antibiotics prophalysis : No / Yes, please specify:
8. Skin preparation
a) Skin antiseptic solution : CH / PVI / SV / ALH
b) Application method : Paint / Scrub / 1 time / 2 times / Other:
c) Drying method Allow to dry / Dried by towel
d) Contact time : min sec
e) Applying staff : (Year of experience: )
f) Unexpected event : No / Yes, please specify:
PART III: POST OPERATIVE INFORMATION

1. SSI developed? : No / Yes
2. Date of SSI diagnosed :
3. Signs and symptoms Fever (>38°C) / Pain / Tenderness / Redness / Swelling /
Watery discharge / Pus / Purulent discharge / Abscess
4. Grade of infection : Superficial / Deep / Organ / Sepsis
5. Wound swab taken No / Yes (Date) (Result)
6. Causative pathogens :
7. Bacterial colony-forming units : CFU/ml
8. Reoperation involved : No / Yes (Date) (Operation)
9. Prolonged hospital stay : No / Yes, days
10. Complication r/t solution : No / Skin allergy / Staining / Others:
REMARKS
60
Appendix X.Staff survey
Evidence-based guidelines for chlorhexidine gluconate in preoperative skin
preparation to reduce surgical site infection in patients undergoing general surgery
Staff survey
Dear all,
We would like to know your comments about the the new guideline: Use of chlorhexidine
gluconate in preoperative skin preparation.
Please circle the appropriate number to show your level of satisfaction.
Comments Least agree Most agree

1. I think the training session is useful.
1 2 3 4 5
2. I understand the reason for the new guideline.
1 2 3 4 5
3. I think the guideline improves quality of care.
1 2 3 4 5
4. I think the training increase my knowledge on the
1 2 3 4 5
new evidence on preoperative skin preparation.
5. I am willing to follow the new guideline.
1 2 3 4 5
6. I can demonstrate preoperative skin preparation with
1 2 3 4 5
proper skills as indicated in the new guideline.
7. I am confident in encouraging surgeons with the use
of chlorhexidine gluconate for skin preparation in 1 2 3 4 5
open surgery.
8. I gain enough assistance from the project team.
1 2 3 4 5
9. I think the new guideline adds more workload to me.
1 2 3 4 5
10. In general, I am satisfied with the new guideline.
1 2 3 4 5
11. Any other comments / difficulties / suggestions?
Sex: M / F
Year of experience: 0-3 / 4-6 / 7-9 / >10
Ranking: EN / SN / SSN / NS / WM
61
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Evidence-based guidelines for chlorhexidine gluconate in

Title preoperative skin preparation to reduce surgical site infection in

Author(s) Lai, Shuk-tin; 黎淑鈿

Issued Date 2013

Rights Creative Commons: Attribution 3.0 Hong Kong License

“Evidence-based Guidelines for Chlorhexidine Gluconate in Preoperative Skin Preparation

to Reduce Surgical Site Infection in Patients Undergoing General Surgery”

Lai, Shuk Tin

for the degree of Master of Nursing

at The University of Hong Kong

In view of this, there is a potential of replacing povidone iodine by chlorhexidine as

preoperative skin antiseptic agent. As there is no existing guideline supportingthis innovative

skin preparation and to develop an evidence-based guideline of using chlorhexidine in

Intercollegiate Guideline Network. Patient characteristics, local clinical setting, organizational

dollars) in six-month period after implementation.

To facilitate a more comprehensive plan in actual implementation of the proposed guideline,

satisfaction, and the overall expenditure.

to Reduce Surgical Site Infection in Patients Undergoing General Surgery”

Lai Shuk Tin

A thesis submitted in partial fulfillment of the requirements for

Table of Contents …………………………………………………………………………….. iii

1.1 Background ………………………………………………………………... 1

1.2 Affirming Needs ………………………………………………………...… 2

1.3 Objectives & Significance ………………...………………………………. 5

CHAPTER 2: CRITCAL APPRAISAL

2.1 Search & Appraisal Strategies ………………………………...................... 7

2.1.1 Identification of studies

2.1.2 Selection Criteria

2.1.3 Data Extraction

2.2.1 Search Results

2.2.2 Study Characteristics

2.3 Summary & Synthesis …………………………………………………….. 14

CHAPTER 3: TRNSLATION AND APPLICATION

3.1 Implementation Period ……………………..……………………………... 19

3.1.1 Transferability of the findings

3.1.3 Cost-benefit ratio of the innovation

3.2 Evidence-based Protocol………………........………..………………….… 26

CHAPTER 4: IMPLEMENTATION PLAN

4.1 Communication Plan...……………………..……..……………………….. 27

4.1.1 Identification of Stakeholders

4.1.2 Communication Process and Strategies

4.2 Pilot Study Plan……………………………………………………………. 29

4.2.2 Target Setting and Population

4.2.3 Time Frame

4.2.4 Outcomes Measure

4.2.6 Analysis and Evaluation of the Pilot Test Results

4.3 Evaluation Plan……………………………………………………………. 32

4.3.2 Nature of Subjects

4.3.3 Sample Size

4.3.4 Timing and Frequency of Outcome Measurement

4.3.5 Analysis of Data

4.3.6 Criteria for Determining Guideline Effectiveness

I Evidence table ………………………………….................................................... 37

II SIGNS Methodology Checklist………………………………………………....... 38

III SIGNS Level of Evidence……………………………………………….……...... 40

IV Quality assessment for individual study ………………………………….…...…. 41

V Estimated set up cost of the new guideline……………........................................ 51

VI Estimated saving from the new guideline.………………………………….…….. 52

VII The evidence-based guideline……………………………………………….…..... 53

VIII Timeline and Communication Plan ………………..………………………….…. 59

IX Data collection sheet.………………………………………………………..…..... 60

X Staff survey …………………………………………………………………….… 61