Ars Pharm.d Fifth Year Project Thesis Final With Result Provii

“COMPLIANCE ASSESSMENT OF ANTIMICROBIAL AGENTS
USED IN THE SURGICAL PROPHYLAXIS FOR CLEAN CASES AT

INTEGRAL INSTITUTE OF MEDICAL SCIENCE AND RESEARCH”
By
ABU RAIHAN SHAMS

ABDULLAH
AHMED NOOR KHAN
ABDUL BASIT
Dissertation submitted to the

Integral University, Lucknow, Uttar Pradesh
In partial fulfillment
for the award of the degree of
DOCTOR OF PHARMACY
Under the guidance of

MR. MOHD. AJMAL
DR. SHAILENDRA MISHRA
DR. MALIK ATIUR RAHMAN
Faculty of Pharmacy
Integral University,
Lucknow-226026
JUNE 2022
DEPARTMENT OF PHARMACY
INTEGRAL UNIVERSITY,
LUCKNOW
THESIS
ON
“Compliance assessment of antimicrobial agents used in the surgical
prophylaxis for clean cases at Integral Institute of Medical Science and

Research”
SUBMITTED BY
ABU RAIHAN SHAMS ABDULLAH AHMED NOOR KHAN ABDUL BASIT

Pharm. D Pharm. D Pharm. D Pharm. D
SUBMITTED TO
Supervisor Co-Supervisor Clinical Co-Supervisor
Mr. Mohd. Ajmal Dr. Shailendra Mishra Dr. Malik Atiur Rahman
Assistant professor Associate professor Assistant Professor
Faculty of Pharmacy Department of Pharmacology, Department of Surgery, IIMSR

IIMS&R
INTEGRAL UNIVERSITY
Accredited by NAAC, Approved by the University Grants Commission under section 2(f) and
12B of the UGC Act 1956, MCI, PCI, IAP, BCI, INC, CoA, NCTE, DEB & UPSMF, Member
of AIU, Recognized as a Scientific & Industrial Research Organization (SIRO) by the Dept. of
Scientific and Industrial Research, Ministry of Science & Technology, Government of India.
Phone No.: 0091-6390011283,84,85 Fax No.: 0522-2890809
Dasauli, Kursi Road, Lucknow-226026 Uttar Pradesh
(INDIA)Web: www.iul.ac.in, e-mail: info@iul.ac.in
Dated:
CERTIFICATE
Mr. Abu Raihan Shams (Roll No. 1700100350), Mr. Abdullah (Roll No. 1700100519),
Mr. Ahmed Noor Khan (Roll No. 1700100571), Mr. Abdul Basit (Roll No. 1700100760)
has carried out and presented the theis titled “Compliance assessment of antimicrobial
agents used in the surgical prophylaxis for clean cases at Integral Institute of Medical
Science and Research” submitted for partial fulfillment for the award of the Degree of
Doctor of Pharmacy from Integral University, Lucknow under my supervision.
It is also certified that:
I. The thesis embodies the original work of the candidate and has not been earlier
submitted elsewhere for the award of any degree/diploma/certificate.
II. The candidate has worked under my supervision for the prescribed period.
III. The thesis fulfills the requirements of the norms and standards prescribed by the
University Grants Commission and Integral University, Lucknow, India.
Therefore, I deem this work fit and recommend for submission for the award of the
aforesaid degree.
Date:
Place: Lucknow
Dr. Tarique Mahmood Ansari
Associate Professor & HOD
Faculty of Pharmacy
Lucknow
INTEGRAL UNIVERSITY
Phone No.: 0091-6390011283,84,85 Fax No.: 0522-2890809
Dated:
CERTIFICATE
has carried out and presented the thesis titled “Compliance assessment of antimicrobial
aforesaid degree.
Date:
Place: Lucknow
Dr. Syed Misbahul Hasan
Professor & Dean Faculty
of Pharmacy
Lucknow
INTEGRAL UNIVERSITY
Phone No.: 0091-6390011283,84,85 Fax No.: 0522-2890809
Dated:
CERTIFICATE
aforesaid degree.
Date:
Place: Lucknow
Dr. Malik Atiur Rahman
Assistant Professor
Department of Surgery,
IIMSR, Integral
University, Lucknow
INTEGRAL UNIVERSITY
Phone No.: 0091-6390011283,84,85 Fax No.: 0522-2890809
Dated:
CERTIFICATE
IV. The thesis embodies the original work of the candidate and has not been earlier
V. The candidate has worked under my supervision for the prescribed period.
VI. The thesis fulfills the requirements of the norms and standards prescribed by the
aforesaid degree.
Date:
Place: Lucknow
Mr. Mohd Ajmal
Assistant Professor
Faculty of Pharmacy,
Lucknow
Table of Contents
I. Declaration
II. Acknowledgement
III. Lists of Tables
IV. List of Abbreviations
Serial Number Title Page Number

1. Abstract
2. Rationale of the Study
3. Introduction
4. Aims and Objectives
5. Review of Literature
6. Methodology
7. Limitations of the study
8. Results
9. Conclusion
10. Discussion
11. Bibliography
12. Appendix
Declaration
We, hereby declare that the work entitled “Compliance assessment of antimicrobial
Science and Research” embodied in this thesis was carried out by us during the academic
session of 2021-22 in the IPD of Surgery Ward of IIMSR, Integral University, Lucknow,
under the supervision and guidance of Mr. Mohd. Ajmal (Assistant Professor, Faculty of
Pharmacy), Dr. Shailendra Mishra (Associate Professor, Department of Pharmacology,
IIMS&R) and Dr. Malik Atiur Rahman (Assistant Professor, Department of Surgery,
IIMS&R). The content and source of information has been derived from the patient profile
form.
Dated:
ABU RAIHAN SHAMS
Pharm. D Vth Year
ABDULLAH
Pharm. D Vth Year
AHMED NOOR KHAN
Pharm. D Vth Year
ABDUL BASIT
Pharm. D Vth Year

Acknowledgement
We, ABU RAIHAN SHAMS, ABDULLAH, AHMAD NOOR KHAN, ABDUL BASIT
would like to express our special thanks of gratitude to our teachers MR. MOHD. AJMAL, DR.
SHAILENDRA MISHRA, DR. MALIK ATIUR RAHMAN as well as our Head, DR.
TARIQUE MAHMOOD ANSARI and Dean, PROF. (DR.) SYED MISBAHUL HASAN
who gave us the golden opportunity to do this wonderful project on “Compliance assessment of
antimicrobial agents used in the surgical prophylaxis for clean cases at Integral Institute of
Medical Science and Research”, which also helped us in doing a lot of research and we came to
know about so many new things we are really thankful to them.
Secondly, we would also like to thank our parents and friends who helped us a lot in finalizing
this project within the limited time frame.
We are overwhelmed in all humbleness and gratefulness to acknowledge our depth to all those
who have helped us to put these ideas, well above the level of simplicity and into something
concrete.
Any attempt at any level can't be satisfactorily completed without the support and guidance ofour
parents and friends.
We would like to thank our parents and friends who helped us a lot in gathering different
information, collecting data and guiding us from time to time in making this project, despite of
their busy schedules, they gave us different ideas in making this project unique.
Thanking you!
Abu Raihan Shams, Abdullah, Ahmed Noor Khan, Abdul Basit

Lists of Tables
Serial No. Title Page No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
List of Abbreviations
WHO: World Health Organization

IIMSR: Integral Institute of Medical Sciences and Research
EDL: Essential Drug List
OPD: Outpatient Department
SSI: Surgical Site Infection
OBG: Obstetrics and Gynecology
RIH: Right Inguinal Hernia
LIH: Left Inguinal Hernia
THR: Total Hip Replacement
LSCS: Lower Segment Caesarean Section
CS: Caesarean Section
NPO: Nil Per Oral
CME: Continuing Medical Education
Abstract
Introduction
Surgery is defined as the treatment of injuries or disorders of the body by incision or manipulation,
especially with instruments. No surgery is possible with absolute nil complications. Both the surgeon
and patient would be always apprehensive on the outcome as well as the complications after a
procedure performed. One such complication is surgical site infection (SSI). SSI is one of the most
commonly occurring complications in daily practice. It is one of the major sources of illness in patients
with post operatives. These infections sometimes cause increase in mortality and morbidity of the
patients. So, Antibiotics Prophylaxis are used to prevent these types of infection during, before and
after surgery. There is a high need to improve compliance with optimal antimicrobial surgical
prophylaxis guidelines so as to reduce risk of SSI. Inappropriate antimicrobial surgical prophylaxis
practice regarding the prescription, timing, and duration of antibiotic use prolongs the hospital stay of
patients, increases patient morbidity (by exposing them to the adverse effects of antibiotics), promotes
bacterial resistance, and puts an economic burden on health care.
Thus, the present study was undertaken for compliance assessment of antimicrobials which are
being used in surgical prophylaxis in clean cases in surgery department of Integral Institute of
Medical Science and Research.
Aims and objectives
• To assess uses of different types antimicrobials used in Surgical prophylaxis for clean cases at
Integral Institute of Medical Sciences and Research.
• To improve the compliance with optimal antimicrobial surgical prophylactic guidelines.

Methods
A prospective, cross-sectional, non-experimental (observational) study was performed in
inpatient department of surgery of Integral Institute of Medical Sciences and Research over a
period of 6 months. During our study a total of 100 prescriptions with 10 types of surgery were
analyzed. The patient demographic details like name, age, sex, place, and weight were noted in
specially designed patient documentation form. Diagnosis, patient complaints, prophylactic
antibiotic, time of administration, Incision time, TLC, Temperature, Post-op Antibiotic, social
history, generic name, brand name, were recorded in patient data collection form.
Results
The mean age of patients was 25.03± 2.55 years. Out of 100 women majority 47% were in the
third trimester. 85 patients were from urban area and 15 patients were from the rural area.
The average number of drugs prescribed was 2.05% per prescription. Most of the drugs were
prescribed by brand name 65% and generic name 35%. Multivitamins 50%, Folic acid 41%
Iron and calcium 35% were the most commonly prescribed drugs, followed by antihistamine
9%, analgesic 8%, anti-emetic 4%, PPI 8% and antibiotic 3%. Mostly, the drugs were of US
FDA risk category A 55% followed by category B 25%, category C 15%, category D 5% and
none of the category X drugs was prescribed. 98% prescriptions had no drug interaction while
1% had minor drug interaction and 1% had moderate drug interactions. There were no major
drug interactions.
Conclusions
In our study, it was found that surgical prophylaxis guidelines was not followed and surgical
prophylaxis compliance was zero percent.
Keywords: IPD, SSI, LIH, RIH, LSCS, THR .
.
Rationale of the Study
• Surgery is defined as the treatment of injuries or disorders of the body by incision or

manipulation, especially with instruments. No surgery is possible with absolute nil
complications. SSI is one of the most commonly occurring complications in daily practice.
• There is a high need to improve compliance with optimal antimicrobial surgical prophylaxis
guidelines so as to reduce risk of SS.
• Inappropriate antimicrobial surgical prophylaxis practice regarding the prescription, timing, and
duration of antibiotic use prolongs the hospital stay of patients, increases patient morbidity (by
exposing them to the adverse effects of antibiotics), promotes bacterial resistance, and puts an
economic burden on health care.
CHAPTER-1
Introduction
1.1 SURGURY
Surgery is a procedure that involves cutting of a patient's tissues or closure of a previously sustained
wound.
Surgery is defined as the treatment of injuries or disorders of the body by incision or manipulation,
especially with instruments.
Appropriately administered antibiotic prophylaxis reduces the incidence of surgical wound infection.
Prophylaxis is uniformly recommended for all clean-contaminated, contaminated and dirty procedures.
It is considered optional for most clean procedures, although it may be indicated for certain patients and
clean procedures that fulfil specific risk criteria. Timing of antibiotic administration is critical to
efficacy. The first dose should always be given before the procedure, preferably within 30 minutes
before incision. Re-administration at one to two half-lives of the antibiotic is recommended for the
duration of the procedure. In general, postoperative administration is not recommended. Antibiotic
selection is influenced by the organism most commonly causing wound infection in the specific
procedure and by the relative costs of available agents.2
Postoperative wound infections have an enormous impact on patients' quality of life and contribute
substantially to the financial cost of patient care. The potential consequences for patients range from
increased pain and care of an open wound to sepsis and even death.3
The occurrence of wound infection requires a local inoculum sufficient to overcome host defences and
establish growth. The process is complex and depends on the interaction of various host, local tissue
and microbial virulence factors. Measures intended to prevent wound infection typically attempt to
modify the host and local tissue factors and include, for example, preoperative optimization of
comorbid illness, control of the operative environment, proper cleansing of the skin and use of aseptic
surgical technique. Antibiotic prophylaxis is only one relatively minor effort among numerous
preventive measures, but the efficacy and impact of antimicrobial prophylaxis has clearly been
demonstrated to be significant.4,5
1.1.1 TYPES OF SURGURY
Surgical procedures are classified based on
1. Urgency
2. Risk and
3. Purpose
1.1.1.1 SURGERY BASED ON URGENCY
1) Elective surgery
2) Urgent surgery
3) Emergency surgery
ELECTIVE SURGERY: It is a procedure that is pre planned and based on patient’s choice and
availability of scheduling for the patient, surgeon and the facility. Delay of surgery has no ill effects.
Examples: Hernia repair, Cataract extraction, Tonsillectomy& Hip prosthesis.
URGENT SURGERY: Must be done with in a reasonably short time frame to preserve health. Usually
done within24 – 48 hours. Examples: Removal of gallbladder, Amputation, Appendectomy.
EMERGENCY SURGERY: Must be done immediately to preserve life, a body part or function.
Examples: Control of hemorrhage, Repair of trauma, perforated ulcers, intestinal obstruction.
1.1.1.2 SURGERY BASED ON DEGREE OF RISK

Major surgery and Minor surgery
MAJOR SURGERY: Major surgery requires hospitalization and specialized care, is usually
prolonged, has a higher degree of risk, involves major body organs or life-threatening situations, and
has a greater risk for postoperative complications. Examples: Open Cholecystectomy, Nephrectomy,
Hysterectomy, Radical mastectomy, Laparotomy.
MINOR SURGERY: Minor surgery is usually brief, carries a low risk and results in few
complications. Minor surgeries are mostly elective. Examples: Teeth extraction, Cataract extraction
1.1.1.3 SURGERIES BASED ON PURPOSE
• Diagnostic
• Ablative
• Palliative
• Reconstructive
• Transplantation
• Constructive
DIAGNOSTIC SURGERY: Surgeries to make or confirm a diagnosis. Examples: Biopsy,
Bronchoscopy, Endoscopy.
ABLATIVE SURGERY: Surgeries To remove a diseased body part. Examples: Appendectomy,
Amputation.
PALLIATIVE SURGERY: Surgeries to relieve or reduce intensity of an illness. It is not curative.
Examples: Colostomy, Nerve root resection
RECONSTRUCTIVE SURGERY: Surgeries to restore function to traumatized or malfunctioning
tissue or to improve self-concept. Examples: Scar revision, Plastic surgery, Internal fixation of a
fracture, Breast reconstruction.
TRANSPLANTATION SURGERY: Surgeries to replace organs or structures that are diseased or
malfunctioning. Examples: Kidney, liver, heart transplantation.
CONSTRUCTIVE SURGERY: Surgeries To restore functions in congenital anomalies. Examples:
Cleft lip Repair, Closure of Atrial Septal Defect.
1.2 SURGICAL PROPHYLAXIS

Wound infections are the commonest hospital-acquired infections in surgical patients.15 They result in
increased antibiotic usage, increased costs and prolonged hospitalization16.
Appropriate antibiotic prophylaxis can reduce the risk of postoperative wound infections, but
additional antibiotic use also increases the selective pressure favoring the emergence of antimicrobial
resistance. Judicious use of antibiotics in the hospital environment is therefore essential. 17
Surgical antibiotic prophylaxis is defined as the use of antibiotics to prevent infections at the surgical
site. It must be clearly distinguished from pre-emptive use of antibiotics to treat early infection, for
example perforated appendix, even though infection may not be clinically apparent. Prophylaxis has
become the standard of care for contaminated and clean-contaminated surgery and for surgery involving
insertion of artificial devices. The antibiotic selected should only cover the likely pathogens. It should
be given at the correct time. For most parenteral antibiotics this is usually on induction of anesthesia. A
single dose of antibiotic is usually sufficient if the duration of surgery is four hours or less. Inappropriate
use of antibiotics for surgical prophylaxis increases both cost and the selective pressure favoring the
emergence of resistant bacteria. Widely accepted indications for antibiotic prophylaxis are contaminated
and clean-contaminated17.
1.2.1 Principles of surgical antibiotic prophylaxis
• Decide if prophylaxis is appropriate

• Determine the bacterial flora most likely to cause postoperative infection (not every species needs
to be covered)
• Choose an antibiotic, based on the steps above, with the narrowest antibacterial spectrum required
• The prophylactic antimicrobial must be given at an appropriate dosage and at an appropriate time
to ensure adequate concentration at the incision site during the period of potential contamination.
Antimicrobial use for dirty and contaminated procedures is not classified as prophylaxis, but
considered as a therapeutic treatment for presumed infection (i.e. non-prophylactic use).
• Choose the less expensive drug if two drugs are otherwise of equal antibacterial spectrum,
efficacy, toxicity, and ease of administration
• Administer dose at the right time
• Administer antibiotics for a short period (one dose if surgery of four hours duration or less)
• Avoid antibiotics likely to be of use in the treatment of serious sepsis
• Do not use antibiotic prophylaxis to overcome poor surgical technique
• Review antibiotic prophylaxis protocols regularly as both cost and hospital antibiotic resistance
patterns may change 17
1.2.2 Commonly used surgical prophylactic antibiotics include:
• Intravenous 'first generation' cephalosporins, cephazolin or cephalothin

• Intravenous gentamicin2nd
• Intravenous or rectal metronidazole (if anaerobic infection is likely)
• Oral tinidazole (if anaerobic infection is likely)
• Intravenous flucloxacillin (if methicillin-susceptible staphylococcal infection is likely)
•
Intravenous vancomycin (if methicillin-resistant staphylococcal infection is likely).17
1.3 WOUND CLASSIFICATION
The definition of a wound is damage to the integrity of biological tissue, including skin, mucous
membranes, and organ tissues. Various types of trauma can cause these, and it is critical to ensure
wounds are cleaned and appropriately dressed to limit the spread of infection and further injury. 1
To correctly classify the cleanliness and condition of wounds, the CDC has established classification
definitions composed of four classes of wound statuses:
• Class 1 wounds are considered to be clean. They are uninfected, no inflammation is present,
and are primarily closed. If the draining of these wounds is necessary, a closed draining
method is necessary. Additionally, these wounds do not enter respiratory, alimentary, genital,
or urinary tracts.
• Class 2 wounds are considered to be clean-contaminated. These wounds lack unusual

contamination. Class 2 wounds enter the respiratory, alimentary, genital, or urinary tracts.
However, these wounds have entered these tracts under controlled conditions.
• Class 3 wounds are considered to be contaminated. These are fresh, open wounds that can
result from insult to sterile techniques or leakage from the gastrointestinal tract into the
wound. Additionally, incisions made that result in acute or lack of purulent inflammation are
considered class 3 wounds.
• Class 4 wounds are considered to be dirty-infected. These wounds typically result from
improperly cared for traumatic wounds. Class 4 wounds demonstrate devitalized tissue, and
they most commonly result from microorganisms present in perforated viscera or the
operative field.18
Clean Wounds These are uninfected operative wounds in which no Surgical

inflammation is encountered and the respiratory, alimentary, Prophylaxis
genital, or uninfected urinary tracts are not entered. In Recommended
addition, clean wounds are primarily closed, and if necessary,
drained with closed drainage. Operative incisional wounds
that follow non-penetrating(blunt)trauma should be included
in this category if they meet the criteria.
Clean- These are operative wounds in which the respiratory, Surgical
Contaminated
alimentary, genital or urinary tract is entered under Prophylaxis
Wounds
controlled conditions and without unusual Recommended
contamination. Specifically, operations involving the
biliary tract, appendix, vagina, and oropharynx are
included in this category, provided no evidence of
infection or major break in technique is encountered.
Contaminated These include open, fresh, accidental wounds, operations Standard
Wounds
with major breaks in sterile technique or gross pillage Antimicrobial
from the gastrointestinal tract, and incisions in which Therapy + Surgical
acute, non-purulent inflammation Prophylaxis
Is encountered.
Dirty or Infected These include old traumatic wounds with retained Standard
Wounds
devitalized tissue and those that involve existing Antimicrobial
Clinical infection or perforated viscera. Therapy + Surgical
Prophylaxis
1.3.1CLASSIFICATION OF OPERATIVE WOUND AND RISK OF INFECTION
Classification Risk (%)
Clean <2
Clean-contaminated < 10
Contaminated ~ 20
Dirty ~ 40
Source: Information from Cruse PJ, Foord R. The epidemiology of wound infection. A 10-year
prospective study of 62,939 wounds. Surg Clin North Am 1980;60:27–40.
ADDITIONAL PATHOGENS BY SITE OF INFECTION

Head and Neck surgery Oral anaerobes
Operations below diaphragm Anaerobes
E. coli and other Enterobacteriaceae
Insertion of a prostheses, graft or shunt Coagulase negative staphylococci, Staph.
aureus, Diphtheroid
1.3.2 Timing
i. Recommendedtimingis15minutesto60minpriortoincisiontimetoensureadequate concentration of
antimicrobial at the incision site.
ii. All surgical prophylaxis antimicrobials except or metronidazole and vancomycin should
administered via intravenous injection over a period of 2-3 minutes.
iii. Metronidazole and vancomycin infusion should be completed 30 minutes before surgical incision
time19
1.3.3 Duration
i. 24-48 hours or less for all surgeries, except cardio thoracic procedures (48-72hours).
ii. Coverage must be provided from time of incision to closure of incision.
iii. Re-administer if excessive bleeding (Blood loss>1,500 ml for adult patient) or change in half-life
of drug (i.e. extensive burns).
iv. May avoid re-administration if half-life is extended (e.g. renal insufficiency).
v. Re-dosing schedule for common antimicrobials.20
vi. Re-dosing requirement into four hours.
1.3.4 Selection of Antibiotics
An appropriate prophylactic antibiotic should
(1) Be effective against microorganisms anticipated to cause infection;
(2) Achieve adequate local tissue levels;
(3) Cause minimal side effects;
(4) Be relatively inexpensive, and
(5) Not be likely to select virulent organisms.
The microbial context of the wound and the hospital environment may influence the choice of
antibiotic, but coverage should primarily target those organisms known to cause postoperative
infection. Species of Staphylococcus may cause infection in the majority of procedures that do not
violate mucosa or a hollow viscus. In general, a first-generation cephalosporin fulfils these criteria
and is regarded as sufficient prophylaxis for the majority of procedures. The most commonly
administered drug is cefazolin (Ancef, Kefzol).
The most common organisms implicated as causes of surgical site infections include6:
• Staphylococcus aureus
• Staphylococcus epidermidis
• Aerobic streptococci
• Anaerobic cocci
Other organisms, such as Cuti bacterium acnes, are characteristically isolated in the setting of
postoperative infections following shoulder surgery.6
In general, the preoperative antibiotic selection is based on the anatomic region undergoing the
specific surgical procedure. When determining appropriate antibiotic selection, the goal is to have
achieved a relatively narrow spectrum of activity while ensuring the most common organisms are
targeted. Additionally, preoperative antibiotics are chosen based on many factors, including cost,
safety, ease of administration, pharmacokinetic profile, bactericidal activity, and hospital resistance
patterns. By addressing all of these factors during antibiotic selection, surgical site infections (SSIs)
are minimized.7
Cefazolin is used most often for surgical prophylaxis in patients with no history of beta-lactam
allergy, a history of MRSA infection, or when consideration is given to surgical sites in which the
most probable organisms that are not covered by cefazolin alone (e.g., appendectomy, colorectal).6
1.3.5 Administration of Antibiotics
The majority of preoperative prophylactic antibiotics are administered intravenously (IV). The initial
timing of administration, redosing, if applicable, duration of prophylactic therapy, and dosing in
obese patients are important components in the prevention of surgical site infections as well as
antimicrobial stewardship.8
Antibiotics should be given within 30 to 60 minutes of a surgical incision. Exceptions include

vancomycin and levofloxacin, which require administration within 120 minutes of the procedural
incision due to longer administration times. If a patient is already receiving an antibiotic for another
infection before surgery, and it is appropriate for surgical prophylaxis, an extra dose of the antibiotic
can be administered within 60 minutes of the incision. If a patient is already receiving vancomycin
and has renal failure, cefazolin should be considered before surgery instead of an extra vancomycin
dose.9
The three antibiotics used in adult surgical prophylaxis, where weight-based dosing is recommended,
are cefazolin, vancomycin, and gentamicin. For patients receiving cefazolin, 2 g is the current
recommended dose except for patients weighing greater than or equal to 120 kg, who should receive
3g. There is some literature stating cefazolin 2 g should be sufficient for a patient at any adult weight.
Vancomycin is dosed at 15 mg/kg, and gentamicin is dosed at 5 mg/kg. Other commonly used
prophylactic antibiotic dosing regimens in adults are clindamycin 900 mg, cefoxitin 2 g, and
ertapenem 1 g. All prophylactic antibiotics for paediatrics are dosed based on milligrams per
kilogram of body weight. Examples of paediatric dosages include the following: cefazolin 30 mg/kg
and vancomycin 15 mg/kg. Paediatric surgical prophylaxis dosages should not exceed the usual adult
dose.6
Antimicrobial Half-life Standard dose Standard dose Re-dosing Route
(Adults), hrs. (Adults) (Pediatrics) interval (from
initiation of
preoperative
dose), hrs.
Cefazolin 1.2-2.2 1 gm, 2 gm for 30mg/kg 4 IV
patients ≥ 80
kg,3gmforpatients
≥120 kg
Cefuroxime 1-2 1.5 gm 50mg/kg 4 IV
Clindamycin 2-4 900 mg 10mg/kg 6 IV
Fluconazole 30 400 6mg/kg NA IV
Gentamicin 2-3 5mg/kg, 2.5mg/kg NA IV
Single dose
Metronidazole 6-8 500 mg 15mg/kg, NA IV
7.5 mg/kg (single
dose)for
neonates<1200gm
Piperacillin- 0.7-1.2 3.375gm Infant: (2-9 mg): 2 IV
tazobactam 80mg/kg of
Piperacillin
component,
Children> 9 &≤40
kg: 100 mg/kg of
Piperacillin component
Vancomycin 4-8 15mg/kg 15mg/kg NA IV
1.4 Recommendations for Specific Categories of Procedures

Prophylaxis is indicated for all procedures not classified as clean. As previously qualified, certain risk
factors justify the use of prophylaxis for clean procedures as well. The following recommendations are
provided for specific procedures. A recent quality standard report that further qualifies the strength of
recommendations based on the quality of available supporting evidence is also useful.10
1.4.1 CUTANEOUS AND SUPERFICIAL SOFT TISSUE PROCEDURES
Prophylaxis is not indicated for cutaneous and superficial soft tissue procedures. For patients with two
or more significant risk factors, prophylaxis is acceptable but not strongly indicated. Traumatic wounds
require consideration of the status of the patient's tetanus vaccination. Although a single dose of
antibiotic is acceptable, mechanical cleansing and adherence to guidelines for open management of
wounds created more than 12 hours before treatment are the essential elements of prophylaxis.2
1.4.2 HEAD AND NECK PROCEDURES
For procedures entailing entry into the oropharynx or oesophagus, coverage of aerobic cocci is
indicated. Prophylaxis has been shown to reduce the incidence of severe wound infection by
approximately 50 percent.11Either penicillin or cephalosporin-based prophylaxis is effective. Cefazolin
is commonly used. Prophylaxis is not indicated for dentoalveolar procedures, although prophylaxis is
warranted in immune compromised patients undergoing these procedures.2
1.4.3 NEUROSURGICAL PROCEDURES
Prophylaxis is currently recommended for craniotomy and shunt procedures. Coverage targets S.
aureus or Staphylococcus epidermidis. Various regimens have been assessed, ranging from
combinations of cefazolin and gentamicin (Garamycin) to single-agent therapy with cefazolin,
vancomycin, piperacillin (Pipracil, Zosyn) and cloxacillin (Cloxapen, Tegapen). No particular regimen
has been clearly demonstrated to be superior.2
1.4.4 GENERAL THORACIC PROCEDURES
Prophylaxis is routinely used for nearly all thoracic procedures, despite the lack of available supportive
evidence (most evidence is based on studies of pulmonary resection for lung cancer).12 Pulmonary
resection in cases of partial or complete obstruction of an airway is a procedure in which prophylaxis is
clearly warranted. Likewise, prophylaxis is strongly recommended for procedures entailing entry into
the oesophagus. Although the range of microorganisms encountered in thoracic procedures is
extensive, most are sensitive to cefazolin, which is the recommended agent.2
1.4.5 CARDIAC PROCEDURES
Prophylaxis against S. aureus and S. epidermidis is indicated for patients undergoing cardiac
procedures. Although the risk of infection is low, the morbidity of mediastinitis or a sternal wound
infection is great. Numerous studies have evaluated antibiotic regimens based on penicillin, first-
generation cephalosporins, second-generation cephalosporins or vancomycin.12,13Cefazolin is an
appropriate agent.2
1.4.6 GASTROINTESTINAL TRACT PROCEDURES
Prophylaxis is recommended for most gastrointestinal procedures. The number of organisms and
proportion of anaerobic organisms progressively increase along the gastrointestinal tract, so the
recommendation depends on the segment of gastrointestinal tract entered during the procedure. The
intrinsic risk of infection associated with procedures entering the stomach, duodenum and proximal
small bowel is quite low and does not support a routine recommendation for prophylaxis. Cefazolin
provides adequate prophylaxis and is the recommended agent.2
Metronidazole can be substituted for erythromycin, and kanamycin (Kantrex) can be substituted for
neomycin. If parenteral prophylaxis is desired, a second-generation cephalosporin with activity against
anaerobic organisms is recommended. Cefotetan and cefoxitin are equally efficacious.2
1.4.7 OBSTETRIC AND GYNECOLOGIC PROCEDURES
Prophylaxis is indicated for caesarean section and abdominal and vaginal hysterectomy. Numerous
clinical trials have demonstrated a reduction in risk of wound infection or endometritis by as much as
70 percent in patients undergoing caesarean section.14 For caesarean section, the antibiotic is
administered immediately after the cord is clamped to avoid exposing the new born to antibiotics.
Despite the theoretic need to cover gram-negative and anaerobic organisms, studies have not
demonstrated a superior result with broad-spectrum antibiotics compared with cefazolin. Therefore,
cefazolin is the recommended agent.2
1.4.8 NONCARDIAC VASCULAR PROCEDURES
Cefazolin is the recommended agent, since most infections are caused by S.aureus or S.epidermidis.
Prophylaxis is not recommended for patients undergoing carotid endarterectomy.2
1.4.9 BREAST AND HERNIA PROCEDURES
Various studies have clearly demonstrated a reduction in the risk of infection by administering
prophylactic antibiotics to patients undergoing breast and hernia procedures, albeit reduction of an
intrinsically low risk. If prophylaxis is desired or indicated for any of these procedures, cefazolin is the
recommended agent.2
1.4.10 Recommended Prophylactic Antimicrobials
Surgeries/Procedures Global Targets Drug and Dose (Adult) Alternative

In India [for paediatric doses, Regimen (in
Benchmark* patients with
refer to re-dosing table]
beta-lactam
allergy)
Cardiothoracic Single dose 48 hrs. - Cefazolin 1 g IV Clindamycin
surgeries maximum of (2gmforpatients≥80kg,3gm 900mg or
72hrs. for patients ≥ 120 kg) OR Vancomycin
Cefuroxime (1.5g 15mg/kg
IV)
Cardiac Device Single dose Single dose Cefazolin 1 g IV Clindamycin
Insertion procedures (2gmforpatients≥80kg,3gm 900mg or
(e.g. Pacemaker) for patients ≥ 120 kg) OR Vancomycin
IV)
Ventricular Assist Single dose Single dose Cefazolin 1 g IV Clindamycin
Device (2gmforpatients≥80kg,3gm 900mg or
for patients ≥ 120 kg) OR Vancomycin
IV)
Valve surgeries Single dose 48 hours- Cefazolin 1 g IV Clindamycin
Maximum (2gmforpatients≥80kg,3gm 900mg or
of 72hours for patients ≥ 120 kg) OR Vancomycin
Cefuroxime (1.5g IV) 15mg/kg
Non-Cardiac Thoracic Single dose 48 hours- Cefazolin 1 g IV Clindamycin
Surgery (incl.
Maximum (2gmforpatients≥80kg,3gm 900mg or
Lobectomy,
Pneumonectomy, etc.)
Gastro-duodenal Single dose Single dose Cefazolin 1 g IV Clindamycin
procedures (2gmforpatients≥80kg,3gm 900mg or
Cefuroxime (1.5g IV) 15mg/kg +
Gentamycin
5mg/kg
Heart, Lung, Heart- Single dose 48 hours- Cefazolin 1 g IV Clindamycin
lung transplantation Maximum (2gmforpatients≥80kg,3gm 900mg or
Liver Transplant Single dose Maximum Piperacillin-tazobactam Clindamycin
(Donor or recipient) 48 hours (4.5g) IV + Fluconazole 900mg or
400 mg (use to be reserved Vancomycin
for indicated cases: see 15mg/kg +
below) † Gentamycin
5mg/kg
Kidney Transplant Single dose Maximum Cefazolin 1 g IV (2gm for Clindamycin
48 hours patients ≥ 80kg,3gm for 900mg or
patients ≥ 120kg) Vancomycin
+ Fluconazole, 400 mg 15mg/kg +
(for patients at high risk Gentamycin
of fungal infection)
5mg/kg
Biliary tract Surgery Single dose 24 hours- Cefazolin 1 g IV Clindamycin

(open procedure) Maximum (2gmforpatients≥80kg,3gm 900mg or
of 48 hours for patients ≥ 120 kg) OR Vancomycin
Gentamycin
5mg/kg
Or
Metronidazole
500mg +
Gentamycin
5mg/kg
Laparoscopic procedure None None None ___________
(Elective, Low risk)
Laparoscopic procedure Single dose 24 hours- Cefazolin 1 g IV Clindamycin
(Elective, High- Maximum (2gmforpatients≥80kg,3gm 900mg or
risk)€[See notes] of 48 hours for patients ≥ 120 kg) OR Vancomycin
Gentamycin
5mg/kg
Or
Metronidazole
500mg +
Gentamycin
5mg/kg
Breast Surgery Single dose Maximum Cefazolin 1 g IV Clindamycin
Conservation/Mastecto of 24 hours (2gmforpatients≥80kg,3gm 900mg or
my /Lumpectomy Or 3 doses for patients ≥ 120 kg) OR Vancomycin
Appendicular surgery Single dose 24 hours- Cefazolin 1 g IV (2gm for Clindamycin
Maximum patients≥80kg, 3gm for 900mg or
of 48 hours patients≥120kg) Vancomycin
+ Metronidazole (500 mg 15mg/kg +
IV) Gentamycin
5mg/kg
Or
Metronidazole
500mg +
Gentamycin
5mg/kg
Small Intestine (Non- Single dose 24 hours- Cefazolin 1 g IV Clindamycin
obstructed) Maximum (2gmforpatients≥80kg,3gm 900mg or
of 48 hours for patients ≥ 120 kg) OR Vancomycin
Small Intestine Single dose 24 hours- Cefazolin 1 g IV (2gm for Metronidazole
(Obstructed Maximum patients≥80kg, 3gm for 500 mg
of 48 hours patients≥120kg) +Gentamicin
+ Metronidazole (500 mg 5mg/kg
IV)
Hernia repair None 24 hours- Cefazolin 1 g IV Clindamycin
(Groin/Incisional) with Maximum (2gmforpatients≥80kg,3gm 900mg or
or without mesh of 48 hours for patients ≥ 120 kg) OR Vancomycin
Colorectal surgery Single dose Maximum Cefazolin 1 g IV (2gm for Clindamycin
48 hrs. patients≥80kg, 3gm for 900mg or
patients≥120kg) Vancomycin
+ Metronidazole (500 mg 15mg/kg +
IV) Gentamycin
5mg/kg
Or
Metronidazole
500mg +
Gentamycin
5mg/kg
Head and Neck–Clean None 24 hrs. – Cefazolin 1 g IV Clindamycin
(including Maximum48 (2gmforpatients≥80kg,3gm 900mg
Thyroidectomy) hrs for patients ≥ 120 kg) OR
Cefuroxime (1.5g IV)
Head and Neck–Clean Single dose 24 hrs. – Cefazolin 1 g IV Clindamycin
with placement of Maximum (2gmforpatients≥80kg,3gm 900mg
prosthesis 48 hrs. for patients ≥ 120 kg) OR
Head and Neck – Clean Single dose 24 hrs. – Cefazolin 1 g IV (2gm for Clindamycin
Contaminated Surgery Maximum patients≥80kg, 3gm for 900mg
(all procedures 48 hrs. patients≥120kg)
involving an incision + Metronidazole (500 mg
through the oral IV)
oropharyngeal mucosa)
Neurosurgery Single dose 24 hrs. – Cefazolin 1 g IV Clindamycin
procedure Maximum (2gmforpatients≥80kg,3gm 900mg or
48 hrs. for patients ≥ 120 kg) OR Vancomycin
Caesarean Section** Single dose 24 hrs. – Cefazolin IV (2gm Clindamycin
(pre-incision Maximum48 For patients ≥80kg,3gm 900Mg +
Gentamicin
or after cord hrs. (Pre- for patients ≥ 120 kg) OR
5 mg/kg
clamping) ** incision or Cefuroxime (1.5 g IV)
after cord
clamping
Hysterectomy Single dose Maximum Cefazolin 1 g IV Clindamycin
(Vaginal or abdominal)
48 hrs. (2gmforpatients≥80kg,3gm 900mg or
Gentamycin
5mg/kg
Or
Metronidazole
500mg +
Gentamycin
5mg/kg
Ophthalmic Topical neomycin– None

Polymyxin B–Gramicidin
or 4thgeneration topical
fluoroquinolones
as1dropevery 5–15 min for
5doses Addition of
Cefazolin100 mg by
subconjunctival injection
or intracameral Cefazolin
1–2.5 mg or Cefuroxime1
mg at the end of procedure
is optional
Orthopedics: - Clean None Maximum Cefazolin 1 g IV Clindamycin
surgeries involving 900Mg +
48 hrs. (2gmforpatients≥80kg,3gm
hand/knee/foot AND Vancomycin
not involving foreign for patients ≥ 120 kg) OR 15 mg/kg
Implants
Orthopedics: - Spinal Single dose Maximum Cefazolin 1 g IV Clindamycin
procedures (with or 900Mg +
without Vancomycin
for patients ≥ 120 kg) OR 15 mg/kg
instrumentation)
Orthopedics: - Hip Single dose Maximum Cefazolin 1 g IV Clindamycin
fracture repair 900Mg +
48 hrs. (2gmforpatients≥80kg,3gm Vancomycin
Orthopedics: - Single dose Maximum Cefazolin 1 g IV Clindamycin
Implantation of internal 900Mg +
fixation devices (e.g. Vancomycin
nails, screws, plates, for patients ≥ 120 kg) OR 15 mg/kg
wires, etc.)
Orthopedics: - Joints Single dose Maximum Cefazolin 1 g IV Clindamycin
replacement 900Mg +
Genito-urinary surgery Single dose Maximum Cefuroxime (1.5 g Clindamycin
Involving implanted
48 hrs. IV)/Cefazolin 1 g IV (2gm 900mg or
prosthesis
for patients≥80kg,3gm for Vancomycin
patients≥120kg) 15mg/kg ±
± Gentamicin (5 mg/kg Gentamicin
IV)
5mg/kg
Genito-urinary surgery Single dose Maximum Cefazolin 1 g IV Clindamycin
900Mg +
15 mg/kg
for patients ≥ 120 kg) OR
Vascular surgery Single dose 24 hrs. – Cefazolin 1 g IV Clindamycin
900Mg +
Maximum48 (2gmforpatients≥80kg,3gm Vancomycin
hrs for patients ≥ 120 kg) OR 15 mg/kg
Plastic surgery Single dose 24 hrs. – Cefazolin 1 g IV Clindamycin
900Mg +
Maximum48 (2gmforpatients≥80kg,3gm Vancomycin
hrs for patients ≥ 120 kg) OR 15 mg/kg
*Based on international guidelines –SIGN, ASHP, NHS
**SIGN guidelines
†Fluconazole prophylaxis is reserved for patients with two or more of the following risk factors:Need
for reoperation, Re-transplantation, Renal failure, Choledochijejunostomy and known colonization
with Candida species
€Factors that indicate a high risk of infectious complications in laparoscopic cholecystectomy
include emergency procedures, diabetes, long procedure duration, intraoperative gall bladder
rupture, age of >70 years, conversion from laparoscopic to open cholecystectomy, American
Society of Anesthesiologists classification of 3or greater, episode of colic within 30 days before the
procedure, re-intervention in less than one month for noninfectious complication, acute
cholecystitis,bilespillage,jaundice,pregnancy,nonfunctioninggallbladder,immune suppression, and
insertion of prosthetic device. Because a number of these risk factors are not possible to determine
before surgical intervention, it may be reasonable to give a single dose of antimicrobial prophylaxis
to all patients undergoing laparoscopic cholecystectomy.
• Patients receiving therapeutic antimicrobials for a remote infection before surgery should also be
given antimicrobial prophylaxis before surgery to ensure adequate serum and tissue levels of
antimicrobials with activity against likely pathogens for the duration of the operation. If the agents
used therapeutically are appropriate for surgical prophylaxis, administering an extradosed within
60 minutes before surgical incision is sufficient. Otherwise, the antimicrobial prophylaxis
recommended for the planned procedure should be used.
• For patients with indwelling tubes or drains, consideration may be given to using prophylactic
agents active against pathogens found in these devices before the procedure, even though
therapeuti c treatment for pathogens in drains is not indicated at other times.
• For patients with chronic renal failure receiving vancomycin, a preoperative dose of cefazolin
should be considered instead of an extra dose of vancomycin, particularly if the probable
pathogens associated with the procedure are gram-negative. In most circumstances, elective
surgery should be postponed when the patient has an infection at remote site.
• For patients with renal or hepatic dysfunction – usually the antimicrobial prophylaxis does not
need modification.
1.4. 11 Antimicrobials not recommended for Surgical Prophylaxis
• Third generation cephalosporins; e.g. Cefotaxime, Ceftriaxone to be avoided

• Fourth generation cephalosporins: e.g. Cefepime, Cefpirome
• Fluoroquinolones to be avoided
• Carbapenes
Justification
According to World Health Organization, drug utilization is defined as the marketing, distribution,
prescription and use of drugs in a society with special emphasis on the resulting medical, social and
economic consequences. Several drug utilization studies on antibiotics are available across the world,
including India.
The study will be performed in a non-profit, secondary care hospital of northern India, Integral
Institute of Medical Sciences and Research hospital (IIMSR). The case records of the patients admitted
to the in-patient department for surgery the surgical procedure will be taken, from the case records, the
details of patients like patient’s identification number, age, gender, vitals, diagnosis, co-morbidities
and the antimicrobial prescription will be taken in a pre-defined Performa.
Antimicrobial prophylaxis study will provide useful insights into the current use of antimicrobial in the
practices and also identify irrational use of antimicrobial. The consequences of irrational uses include
non-adherence of surgical guideline, which can result in prolongs the hospital stay of patients,
increases patient morbidity (by exposing them to the adverse effects of antibiotics), promotes bacterial
resistance, and puts an economic burden on health care.In view of above, the present study is designed
to assess the compliance of antimicrobial agents used in the surgical prophylaxis for clean cases at
tertiary care teaching hospital. Based on international guidelines –SIGN, ASHP, NHS we assess the
compliance parameter of surgical prophylaxis like, name and time antimicrobial administered, time of
incision, re-dosing, duration of antimicrobials used, pre and post op temperature, and TLC.
Aims and Objectives
Aims
Compliance assessment of antimicrobial agents used in the surgical prophylaxis for clean cases at
Integral Institute of Medical Science and Research
Objectives
• Primary objective- To assess uses of different types antimicrobials used in Surgical prophylaxis for
clean cases at IIMS&R.
• Secondary objective- Monitoring of antibiotics used in surgical prophylaxis.
CHAPTER-2
Review of literature
Author Technique/method Year Result

Hospital based prospective 2018 About 84% of the study participants
Gregory W.Jet al., and observational study. received ceftriaxone. Majority of the
prophylactic antibiotics (75.8%) will
administered for greater than 24 hours
and above half (52.3%) of the
antibiotics will administered
preoperatively.
About 97% of the patients will
discharged with improvement.
Majority of the participants will from
the general surgical ward (60.1%)
JC Mwitaet al., Prospective observational 2014-2015 The most common operations will
study. exploratory laparotomy (25%),
appendectomy (18.3%), excision, and
mastectomy (8%). Antibiotics will
given in 73.3% of patients, mainly
postoperatively (58.3%). The most
commonly prescribed antibiotics will
cefotaxime
(80.7%), metronidazole (63.5%),
cefradine (13.6%) and
amoxicillin/clavulanate (11.6%).
Interventions are in place to decrease
SSI rates to acceptable levels in this
leading hospital by improving for
instance infection prevention practices
including the timing of antibiotic
prophylaxis.
SZ Buttet al., A prospective quasi 2019 This intervention resulted in

experimental study significant reductions in the duration
and average number of antibiotic use
having considerable effect on therapy
and hospitalization cost.
he benefit of pharmacist intervention,
mean antibiotic cost savings to mean
cost of pharmacist time, was 4.8:1.
AK Labiet al., Prospective study 2018 Prevalence was highest among
Pediatric surgery where 20/22 patients
(90.9%, 95% CI, 70.8–98.9) will
administered antibiotics and lowest
among Obstetrics patients with 77/214
(36%, 95% CI, 29.5–42.8). The
indications for antibiotic use will
245/611 (40.1%) for community-
acquired infections, 205/611 (33.6%)
for surgical prophylaxis, 129/611
(21.1%) for healthcare associated
infections and 33/611 (5.4%) for
medical prophylaxis. The top five
antibiotics prescribed in the hospital
will metronidazole 107 (17.5%),
amoxicillin-clavulanic acid 82
(13.4%), ceftriaxone 17(12.1%),
cefuroxime 61 (10.0%), and
cloxacillin 52 (8.5%) respectively.
Prevalence of meropenem and
vancomycin use was 12(2%) and 1
(.2%) respectively. The majority of
patients 181 (52%) will being treated
with two antibiotics.
AKR Purba,et al., Data based study 2018 Twenty-four bacteria will be
identified as causative agents of SSIs.
Gram negatives will the dominant
causes of SSIs especially in general
surgery, neurosurgery, cardiothoracic
surgery, and obstetric caesarean,
sections.
S. M. McHughet al., Data based study 2011 The local intraoperative

administration of antibiotic
prophylaxis commonly performed in
other orthopedic procedures,
plastic/dermatological surgery and
abdominal surgical procedures in non-
obese patients remains under
evaluated and, to date, unproven.
Topical antibiotics as surgical
prophylaxis can only be recommended
where there are prospective
randomized trials demonstrating clear
efficacy
L Prokuskiet al., Evaluation 2008 The use of prophylactic antibiotics in
of a multi- orthopedic surgery is effective in
site reducing SSI rates in studies of hip
intervention
and knee, arthroplasty spine surgery,
by time
series and open reduction and internal
analysis fixation of fractures. To maximize the
beneficial effect of prophylactic
antibiotics while minimizing adverse
effects, the correct antimicrobial must
be selected, the drug must be
administered just before incision, and
duration of administration should not
exceed 24 hours.
CHAPTER-3
Methodology
Study Design: Non-experimental, Prospective study.
Study Site: Study will be carried out in the IPD and different surgery wards for consecutive
6 months at Integral University Hospital; a 500 bedded teaching hospital situated in the
premises of Integral University, Lucknow. Almost all the recording systems of the hospital
during the study period will be carried out manually.
Study Duration: The study was carried out for 6 months at Integral Institute of Medical
Sciences and Research (IIMSR).
Departments Involved: Gynecologic, and obstetrics, Orthopedic Ward and Department of

Surgery, Integral Institute of Medical Sciences and Research and Faculty of Pharmacy,
Integral University.
Study Population: Study is conducted on 100 patients during study period at Integral
University Hospital, who will attending and willingly participating from the gynecologic, and
obstetrics, general surgical and orthopedic, wards during the study period will considered as
the study population and those that fulfil, the inclusion criteria will be included; subjects will
be enrolled on the basis of inclusion and exclusion criteria.
Sources of data
1. Preanesthesia chart
2. Physician Notes
3. Patient medication profile
Selection of patients
Inclusion Criteria
• All the patients came for surgical procedure; of irrespective the age and sex attending
the IPD will be included in the study.
• Only clean surgical procedures will be considered
• Consider LSCS, D&C procedure, TKR, THR, bone grafting, lap cholecystectomy,
Herniorrhaphy, Hydrocelectomy, Splenectomy, Laminectomy
Exclusion Criteria
• Patient who are not treated with any surgery.

• Patient unable to comply.
• Clean contaminated, contaminated and Dirty procedures
Method and Materials used
The data will be collected in a predesigned Performa from the medical case sheets, drug charts,
and laboratory investigations of 100 in-patients. The enrolled patients will be observed from
admission till discharge. Descriptive statistics will be applied to the collected data and analyzed
using Microsoft Excel software.
Data Collection
The following data will be collected based on the questionnaire.
1. Date of surgery.
2. Name of Doctor.
3. Name of surgery, Types of surgery.
4. Name of Prophylactic Antibiotic.

5. Dose of Antibiotic
6. Time of administration of Antibiotic
7. Route of Administration
8. Time of incision
9. Re-dosing Antibiotic
10. Additional Antibiotic after surgery or during surgery
11. The finally appropriate SAP usage assessment lists (indication, selection, duration, and
timing)
Evaluation parameters
The following parameters will be evaluated:
• GFR (glomerular filtration rate)
• Hba1c test or blood sugar
• Blood test
• Pre-operation and Post-operation temperature,
• Post of TLC (total leukocyte count)
• Discharge Antibiotic
Outcome of the study
• This present study will help us to understand the most commonly prescribed prophylactic
antimicrobial drug and some evaluation parameter in department of surgery in in-patient
department.
Statistical analysis
• Descriptive statistics will be applied to the collected data using Microsoft Excel software.
Results are expressed in percentages and mean-standard deviation (SD).
• ANOVA / Student’s t- test will be applied on the collected data to evaluate the statistical
significance.
Ethical considerations
• The study was complied fully with the WHO guidelines and done after obtaining approval
from Institutional Research and Ethics Committee.
Limitations of the study
• The study neither provide information on drugs dispensed in outpatient settings

norover the counter medications (self medication), it only limited to the prescribed
drugs.
• The study is limited to urban area and it does not assess the practice of drug
use inrural community, so generalization of the result is not possible.
• In this study we analyzed only IPD patients.
CHAPTER-4
Results
• The study was conducted over a period of 6 months in an out-patient department of

Surgery of Integral Institute of Medical Sciences and Research.
• A total of 100 prescriptions were observed and the following evaluations were made.
1. Age Distribution among study subject
▪ Most of patients were from age group 20-30 (31%) and lowest no of patients were from
age group <20 (2%) whereas moderate were from 41-50 (18%).
Age Pattern Male Female Total
31 29
9 18
17 12
22 9 8
12 9 9 7
2
1
0 0 0 0 3
0 1
0
Fig: Age Distribution of Study Subjects

2. Gender Distribution among study subject
▪ Among 100 patients, 48% patients were male and 52% patients were female.
Gender No of Patients
Patients (%)
Male 48 48%
Female 52 52%
Total 100 100 %
Male Female
48%
52%
Fig: Gender distribution of study subjects

3. Different types of surgery done in study subjects
▪ Maximum no of surgical Patients in our study subject were Cholecystectomy (47%) and
lowest no of patients were THR(3%) and Appendicitis (3%).
3% 3% 4%
5%
23%
47% 15%
Hydroclelectomy Hernioplasty LSCS

Cholecystectomy THR Appendicitis
Other
Fig: No of Patients having different types of surgeries

4. Different types of Pre-op Prophylactic Antibiotic used
▪ The most commonly used Pre-op Prophylactic antibiotic was found to be Injection
Monocef (98%).
Name of Pre-op Prophylactic No of Patients

Antibiotic
Monocef 1gm 98
Magnex 1.5gm 2
Magnex
1.5gm
2%
Monocef
1gm
98%
Fig: Pre-op Prophylactic Antibiotics

5. Compliance of LSCS
▪ For LSCS, appropriate prophylactic agents is 1st generation cephalosporin like Cephazolin
but in our study subject Monocef (Ceftriaxone) was being used so compliance is 0%.
▪ According to standard guidelines incision should be done within 60 min after
administration of prophylactic agent but in 2 cases incision was done after 60 min so
compliance is 87%.
▪ Since this procedure is of clean case so redosing is not required and in all cases redosing
were not done, so compliance is 100%.
▪ In clean case, duration of antibiotic should be upto 48 hours but in our study subject
prophylactic antibiotics were continued for more than 48hrs, so compliance is 0%.
Compliance Evaluation Compliance % 120% Compliance %

Parameter 100%
80%
Appropriate Prophylactic 0%
60%
Agents used 100%
40% 80%
Incision Time 87%
20%
Redosing 100% 0% 0% 0%
Duration of Prophylactic 0%
agent
Fig: Compliance of LSCS
6. Compliance of Cholecystectomy
Compliance Compliance %
Evaluation Parameter
Appropriate 0% Duration of 0%
Prophylactic agent
Prophylactic Agents
used Redosing 100%
Incision Time 91% 91%

Incision Time
Redosing 100%
Appropriate 0%
Prophylactic…
Duration of 0%
0% 50% 100%
Fig: Compliance of Cholecystectomy
Prophylactic agent
7. Compliance of Hernioplasty
Compliance Compliance % Compliance %

Evaluation Parameter
100%
90%
80%
Appropriate Prophylactic 0%
70%
Agents used
60%
50% 100%
87%
40%
Incision Time 91%
30%
20%
10%
0% 0% 0%
Redosing 100%
Duration of Prophylactic 0%
agent
Fig: Compliance of Cholecystectomy
8. Overall Compliance
▪ For all type of clean cases, appropriate prophylactic agents is 1st generation cephalosporin
like Cephazolin but in our study subject (Monocef) Ceftriaxone were being used in 98
patients and (Magnex) Cefoperazone is used in 2 patients, so compliance is 0%.
▪ According to standard guidelines, incision should be done within 60 min after
administration of prophylactic agent but in 9 cases out of 100 the incision was done after
60 min, so compliance is 91%.
▪ Since this procedure is of clean case so redosing is not required and in all cases redosing
were not done, so compliance is 100%.
▪ In clean case, duration of antibiotic should be upto 48 hours but in our study subject
prophylactic antibiotics were continued for more than 48hrs so compliance is 0%.
Compliance Evaluation Parameter Compliance %
Appropriate Prophylactic Agents used 0%
Incision Time 91%
Redosing 100%
Duration of Prophylactic agent 0%
100%
91%
100%
80%
60%
40%
20% 0% 0%
0%
Appropriate Incision Time Redosing Duration of
Prophylactic Prophylactic
Agent used agent
Fig: Overall Compliance

CHAPTER-5
Conclusion
▪ According to standard surgical prophylactic guidelines recommended prophylactic agent is

Cefazolin, but in our study subject most prescribed prophylactic agents were Monocef
(Ceftriaxone) in 98% and Magnex (Cefoperazone) in 2%, So compliance is 0%.
▪ Duration of antibiotic used in clean case surgeries are upto 48 hours but in our study
average duration was 6.5 days, so here also compliance is 0%.
▪ Incision should be done within 60 min after administration of prophylactic agent but in our
study, 9 cases out of 100 the incision was done after 60 min so compliance is 91%.
▪ Redosing should not be done in clean case type of surgery, in our study subjects no
redosing were done in any cases, so compliance is 100%.
CHAPTER-6
Discussion
▪ It was observed that more than 200 persons having various complications were admitted in
inpatient department of surgery of IIMS&R during the period of 6 months of our study.
▪ We had selected 100 patients on the basis of inclusion and exclusion criteria for the study.
▪ Demographic characteristics showed that highest number of clean cases surgery patients
were females(52%) as compared to males(48%).
▪ Further it was found that maximum no of patients were from age group 20-30 (31%) and
lowest no of patients were from age group <20 (2%).
▪ Further it was observed that highest number of clean cases surgeries that were performed
were cholecystectomy (47%) and lowest were THR(3%) and appendicitis(3%).
▪ In this study, 100 prescriptions were analyzed and it was found that total 100 pre-op
prophylactic antibiotic were being prescribed in which maximum no of prescribed
antibiotic were Monocef (Ceftriaxone) (98%) and lowest were Magnex (2%).
▪ According to standard surgical prophylaxis guidelines, Cefazolin is the most used
antibiotic in preoperative prophylaxis but in our study the most commonly prescribed pre-
op antibiotic was found to be Monocef (98%) which shows 0% compliance.
▪ The compliance for incision time is 91% as incision should be done within 60 min after
administration of prophylactic agent but in our study, 9 cases out of 100 the incision was
done after 60 min.
▪ The redosing compliance is 100%, as in clean cases of surgery redosing is not required,
and in our study redosing were not done in any cases of surgery.
CHAPTER-7
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12. Doebbeling BN, Pfaller MA, Kuhns KR, Massanari RM, Behrendt DM, Wenzel RP.
Cardiovascular surgery prophylaxis. A randomized, controlled comparison of cefazolin and
cefuroxime. J ThoracCardiovascSurg. 1990;99(6):981–9.
13. Ariano RE, Zhanel GG. Antimicrobial prophylaxis in coronary bypass surgery: a critical
appraisal. DICP. 1991;25:478–84[Published erratum appears in DICP 1991;25:876]
14. Hemsell DL. Prophylactic antibiotics in gynecologic and obstetric surgery. Rev Infect Dis.
1991;13(Suppl 10):S821–41.
15. Horan TC, Culver DH, Gaynes RP, Jarvis WR, Edwards JR, Reid CR, National Nosocomial
Infections Surveillance (NNIS) System. Nosocomial infections in surgical patients in the United
States, January 1986-June 1992. Infection Control & Hospital Epidemiology. 1993 Feb;14(2):73-80.
16. McGowan Jr JE. Cost and benefit of perioperative antimicrobial prophylaxis: methods for
economic analysis. Reviews of infectious diseases. 1991 Sep 1;13(Supplement_10):S879-89.
17. Munckhof W. Antibiotics for surgical prophylaxis. Munckhof W. Antibiotics for surgical
prophylaxxis.
18. Onyekwelu I, Yakkanti R, Protzer L, Pinkston CM, Tucker C, Seligson D. Surgical wound
classification and surgical site infections in the orthopaedic patient. Journal of the American Academy
of Orthopaedic Surgeons. Global Research & Reviews. 2017 Jun;1(3).
19. Bratzler DW, Houck PM, Workgroup SI. Antimicrobial prophylaxis for surgery: an advisory
statement from the National Surgical Infection Prevention Project. The American Journal of Surgery.
2005 Apr 1;189(4):395-404.

20. Branch-Elliman W, O’Brien W, Strymish J, Itani K, Wyatt C, Gupta K. Association of duration
and type of surgical prophylaxis with antimicrobial-associated adverse events. JAMA surgery. 2019
Jul 1;154(7):590-8.
21. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR, Hospital Infection Control Practices
Advisory Committee. Guideline for prevention of surgical site infection, 1999. Infection Control &
Hospital Epidemiology. 1999 Apr;20(4):247-80.
22. B j or g Marit Anderson, Additional article information, Nature Publishing Group 1.5 Need of
study 3rd line.

CHAPTER-8
INTEGRAL UNIVERSITY, LUCKNOW
INFORMED CONSENT FORM
SUPERVISOR INVESTIGATORS
Mr. Mohd Ajmal Abu Raihan Shams

Assistant Professor Pharm. D 5th Year
Faculty of Pharmacy Department of Pharmacy
Integral University 9599848686
9891216062
CO-SUPERVISOR Abdullah
Pharm. D 5th Year
Dr. Shailendra Mishra Department of Pharmacy
9919382268
Associate Professor
Department of Pharmacology
IIMS&R Integral University
AHMED NOOR KHAN

Pharm. D 5th Year
CLICINAL SUPERVISOR Department of Pharmacy
8318515759
DR. Malik Atiur Rahman
Assistant Professor
Department of Surgery
IIMS & R, Integral University
ABDUL BASIT
Pharm. D 5th Year
Department of Pharmacy
7007502352
PATIENT INFORMATION SHEET
TITLE: Compliance assessment of antimicrobial agents used in the surgical prophylaxis for clean
cases at Integral Institute of Medical Science and Research.
PURPOSE: Compliance assessment of antimicrobial agents used in the surgical prophylaxis for clean
cases.
ELIGIBILITY:
You can participate in this study if:

1. You are diagnosed for surgery treatment in IPD of the hospital.
2. You will be included irrespective of sex and between 18-65 years of age.
You cannot participate in this study if you have:

1. If you are mentally retarded and unconscious patients
2. If you are not diagnosed with any type of surgery treatment.
3. If you are unable to comply
4. If you are a Drug addict
CONSENT
Sample signature page for research involving patient
I am making this decision whether or not to take participate in this study. My signature
indicates that I have read and understood the patient information sheet provided above and
decided to participate.
Signature and name of patient/guardian Date
Signature and name of witness-1 Date
Signature and name of witness-2 Date
Signature and name of investigator Date

INTEGRAL INSTITUTE OF MEDICAL SCIENCES & RESEARCH
Integral University Lucknow
Dasauli, Kursi Road, Lucknow-226026
INFORMED CONSENT FORM

Name of patient…………………………………………………………
Telephone no.-……………
TITLE of research/study: Compliance assessment of antimicrobial agents used in the surgical
prophylaxis for clean cases at Integral Institute of Medical Science and Research.
Address of patient
Date of birth / age……………………
I declare that, I have read the consent form / consent form has been read. Research done on me in my
own language / the study and testing is well understood and to get any kind of information in this
subject / Full time to query is provided. I can be separated from the study at any time without giving
any reason, without affecting my medical care or statutory rights. I also understand that those who do
this research/study conduct studies, ethics committee or other regulatory institute / institutions. Without
my consent, my health record will be used in current studies and next other research. I also understand
that my identity and other information will not be shared or published by any third party. In case of
being dissuaded from my research, I agree to use all the data / results related to this which will be
obtained from this research only for scientific publication. I consent to the stored and preserved
specimens of my blood be used in future research.
I am told I will not have to pay for any type of test. All payment will be made by Investigator.
I am told that in case of any accidental complication occurring during the test, all assistance will be
provided by Mr. Abu Raihan Shams, Abdullah, Ahmed Noor Khan & Abdul Basit Contact number
9599848686, 9919382268, 8318515759.
I have been told that blood sample will be taken from the vein, taking all precautions to participate in
the study/ Machine will check the heart / lungs / Body parts will be measured.
Complications such as. ................................................................................................................... Arising

out of the said type of sample collection / testing etc, have been well understood to me.
Thumb impression / signature of the patient / person……………………………………………………

The person's name………………………………………………date……………………
Signature of Investigator………………………………………………….…....date…………………….
Name of Investigator……………………………
Signature of witness 1………………………………………………date……………………
Name of witness 1…………………………………………………………………….
Signature of witness 2………………………………………………date……………………
Name of witness 2…………………………………………………………………….
Phone No: - +91(0522)2890812, 289073, 3296117, 6451039, Fax No: +91-(0522)-289080

Doctor of Pharmacy Thesis 67 Integral University
इं टीग्रल इं स्टिट्यूट ऑफ़ मेडिकल साइं स एं ि रिसर्च
इं टीग्रल यूनिवनसिटी,
दसौली , कुसीरोड , लखिऊ-226026
सूडर्त सहमडत पत्र
रोगीकािाम.......................................................................... टे लीफोि िं.-...............
अिुसंधाि/अध्ययि का शीर्िक: स्वच्छ मामलों के नलए सनजिकल प्रोनफलैक्सिस में प्रयुक्त रोगाणुरोधी एजेंटों का अिुपालि
आकलि
जन्मनिनि /आयु....................................
मैं घोर्णा करिा/करिी हूँ नक मैंिे सहमनि प्रपत्र पढ़ नलया है। मुझ प zर मेरी अपिी भार्ा में नकया गया शोध/अध्ययि और
परीक्षण अच्छी िरह से समझा जािा है और इस नवर्य में नकसी भी प्रकार की जािकारी प्राप्त करिे के नलए /पूछिे के नलए
पूणिकानलक प्रदाि नकया जािा है । मुझे नििा कोई कारण ििाए, मेरी निनकत्सा दे खभाल या वैधानिक अनधकारों को प्रभानवि
नकए नििा नकसी भी समय अध्ययि से अलग नकया जा सकिा है । मैं यह भी समझिा हं नक जो लोग इस शोध/अध्ययि को
करिे हैं वे अध्ययि, िैनिकिा सनमनिया अन्य नियामक संस्िाि/संस्िािों का संिालि करिे हैं । मेरी सहमनि के नििा, मेरे
स्वास्थ्य ररकॉडि का उपयोग वििमाि अध्ययिों और अगले अन्य शोधों में नकया जाएगा। मैं यह भी समझिा हं नक मेरी पहिाि
और अन्य जािकारी नकसी िीसरे पक्ष द्वारा साझा या प्रकानशि िहीं की जाएगी। अपिे शोधकायि से नविनलि होिे की क्सस्िनि में
मैं इससे संिंनधि समस्त आूँ कडों/पररणामों का उपयोग करिे के नलए सहमि हूँ जो इस शोध से प्राप्त होंगे केवल वैज्ञानिक
प्रकाशि के नलए। मैं अपिे रक्त के संग्रहीि और संरनक्षि िमूिों को भनवष्य के अिुसंधाि में उपयोग करिे के नलए सहमि हं ।
मुझे ििाया गया है नक मुझे नकसी भी प्रकार के परीक्षण के नलए भुगिाि िहीं करिा होगा। सभी भुगिाि अन्वेर्क द्वारा नकया
जाएगा।
मुझे ििाया गया है नक परीक्षणके दौराि होिे वाली नकसी भी आकक्सिक जनटलिा केमामले में, श्री अिूरेहाि शम्स, अब्दु ल्ला,
अहमद िूर खाि, अब्दु ल िानसि द्वारा सभी सहायिा प्रदाि की जाएगी। संपकि संख्या 9599848686, 9919382268,
8318515759.
मुझे ििाया गया है नकि से रक्त का िमूिा नलया जाएगा, अध्ययि में भाग लेिे के नलए सभी सावधािी िरििे हुए/मशीि द्वारा
हृदय/ फेफडे / शरीर के अंगों की जां ि की जाएगी।
जैसी जनटलिाएं ……………………………………… ……………………………………… ............... उक्त प्रकार के

िमूिा संग्रह / परीक्षण आनद से उत्पन्न, मुझे अच्छी िरह से समझा गया है ।
रोगी/व्यक्सक्त के अंगूठे का निशाि/हस्ताक्षर ………………………………………

व्यक्सक्त का िाम ……………………………………… िारीख………………………
अन्वेर्क का हस्ताक्षर………………………………………………………… िारीख………………
अन्वेर्क का िाम………………………..
गवाह 1 का हस्ताक्षर………………………………………………िारीख………………
गवाह 1 का िाम …………………………………………………………….
गवाहक 2 का हस्ताक्षर………………………………………………िारीख……………………..
गवाह 2 का िाम…………………………………………………………….
फोि िंिर: - +91(0522)2890812, 289073, 3296117, 6451039, फैि िंिर: +91-(0522)-289080


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“COMPLIANCE ASSESSMENT OF ANTIMICROBIAL AGENTS

USED IN THE SURGICAL PROPHYLAXIS FOR CLEAN CASES AT

ABU RAIHAN SHAMS

Dissertation submitted to the

Under the guidance of

“Compliance assessment of antimicrobial agents used in the surgical

prophylaxis for clean cases at Integral Institute of Medical Science and

ABU RAIHAN SHAMS ABDULLAH AHMED NOOR KHAN ABDUL BASIT

Supervisor Co-Supervisor Clinical Co-Supervisor

Assistant professor Associate professor Assistant Professor

Faculty of Pharmacy Department of Pharmacology, Department of Surgery, IIMSR

Serial Number Title Page Number

ABU RAIHAN SHAMS

Pharm. D Vth Year

Pharm. D Vth Year

AHMED NOOR KHAN

Pharm. D Vth Year

Pharm. D Vth Year

know about so many new things we are really thankful to them.

this project within the limited time frame.

parents and friends.

Abu Raihan Shams, Abdullah, Ahmed Noor Khan, Abdul Basit

WHO: World Health Organization

• To improve the compliance with optimal antimicrobial surgical prophylactic guidelines.

• Surgery is defined as the treatment of injuries or disorders of the body by incision or

1.1.1.2 SURGERY BASED ON DEGREE OF RISK

1.2 SURGICAL PROPHYLAXIS

• Decide if prophylaxis is appropriate

1.2.2 Commonly used surgical prophylactic antibiotics include:

• Intravenous 'first generation' cephalosporins, cephazolin or cephalothin

• Class 2 wounds are considered to be clean-contaminated. These wounds lack unusual

Clean Wounds These are uninfected operative wounds in which no Surgical

1.3.1CLASSIFICATION OF OPERATIVE WOUND AND RISK OF INFECTION

Classification Risk (%)

ADDITIONAL PATHOGENS BY SITE OF INFECTION

1.3.5 Administration of Antibiotics

Antibiotics should be given within 30 to 60 minutes of a surgical incision. Exceptions include

1.4 Recommendations for Specific Categories of Procedures

1.4.1 CUTANEOUS AND SUPERFICIAL SOFT TISSUE PROCEDURES

1.4.2 HEAD AND NECK PROCEDURES

1.4.3 NEUROSURGICAL PROCEDURES

1.4.4 GENERAL THORACIC PROCEDURES

1.4.5 CARDIAC PROCEDURES

1.4.7 OBSTETRIC AND GYNECOLOGIC PROCEDURES

1.4.8 NONCARDIAC VASCULAR PROCEDURES

1.4.9 BREAST AND HERNIA PROCEDURES

Surgeries/Procedures Global Targets Drug and Dose (Adult) Alternative

Biliary tract Surgery Single dose 24 hours- Cefazolin 1 g IV Clindamycin

Ophthalmic Topical neomycin– None

*Based on international guidelines –SIGN, ASHP, NHS

1.4. 11 Antimicrobials not recommended for Surgical Prophylaxis

• Third generation cephalosporins; e.g. Cefotaxime, Ceftriaxone to be avoided

and the antimicrobial prescription will be taken in a pre-defined Performa.

Author Technique/method Year Result

SZ Buttet al., A prospective quasi 2019 This intervention resulted in

S. M. McHughet al., Data based study 2011 The local intraoperative

Study Design: Non-experimental, Prospective study.

Departments Involved: Gynecologic, and obstetrics, Orthopedic Ward and Department of

• Only clean surgical procedures will be considered

• Patient who are not treated with any surgery.

Method and Materials used

The following data will be collected based on the questionnaire.

3. Name of surgery, Types of surgery.