Original Paper
Dig Surg
DOI: 10.1159/000488214
Effectiveness of Wound-Edge Protectors for
Preventing Surgical Site Infections after Open
Surgery for Colorectal Disease: A Prospective
Cohort Study with Two Parallel Study Groups
Hirotoshi Kobayashi a Hiroyuki Uetake b Masamichi Yasuno b
Kenichi Sugihara b  
a Departmentof Surgery, Tokyo Metropolitan Hiroo Hospital, Tokyo, Japan; b Department of Surgical Oncology,
Graduate School, Tokyo Medical and Dental University, Tokyo, Japan
Keywords
Wound-edge protector · Surgical site infection ·
Colorectal surgery
Abstract
Background: Standard procedures to reduce the surgical
site infection (SSI) rate after colorectal surgery have not been
established. A prospective cohort study with 2 parallel study
groups was performed to clarify the SSI rate after open sur-
gery with and without a wound-edge protector (WEP) for
colorectal disease. Methods: A total of 102 patients who un-
derwent elective open surgery for colorectal disease be-
tween October 2012 and August 2014 were randomly as-
signed to a WEP group and a WEP (–) group. The primary
endpoint was the SSI rate in both groups. Results: Fifty-one
patients were assigned to the WEP group and 51 to the WEP
(–) group. Two patients were excluded from this study. The
rate of SSI with and without a WEP was 16 and 36% respec-
tively (p = 0.021). Older age (p = 0.0073) and no WEP (p =
0.021) were risk factors for SSI after open surgery for colorec-
tal diseases on univariate analysis. On multivariate analysis,
both older age (p = 0.016) and no WEP (p = 0.012) were inde-
© 2018 S. Karger AG, Basel
E-Mail karger@karger.com
www.karger.com/dsu
Received: October 20, 2017
Accepted: March 7, 2018
Published online: April 26, 2018
pendent risk factors for SSI. Conclusion: The present ran-
domized, phase II trial found an SSI rate of 16% with use of a
WEP. The SSI rate was lower in the WEP group than in the
WEP (–) group. A WEP may reduce the SSI rate after open
surgery for colorectal disease in Japanese patients.
© 2018 S. Karger AG, Basel
Introduction
Colorectal cancer is the second most common cause of
cancer mortality in the United States and Japan [1, 2].
Furthermore, the incidence of colorectal cancer is in-
creasing rapidly in Japan [2, 3].
Surgery is one of the primary treatment modalities for
colorectal disease. Although laparoscopic surgery has
prevailed, open surgery is still performed with some fre-
quency. One of the most frequent complications after
colorectal surgery is surgical site infection (SSI). The re-
ported incidence after colorectal surgery ranges from 4.7
to 27% [4–6]. SSI leads to a prolonged hospital stay and
increased medical costs. An English study reported that
superficial and deep SSIs led to extra costs of EUR 2,267
129.49.5.35 - 6/4/2018 7:38:23 PM
HSC Library-Serials Dept., SUNY
Hirotoshi Kobayashi, MD, FACS
Director, Department of Surgery
Tokyo Metropolitan Hiroo Hospital
2-34-10 Ebisu, Shibuya-ku, Tokyo 150-0013 (Japan)
Downloaded by:
E-Mail h-kobayashi.srg2 @ tmd.ac.jp
and 3,662, respectively [7]. Therefore, it is essential to re-
duce the incidence of SSI, which would improve patients’
quality of life and decrease medical costs.
A wound-edge protector (WEP) has been used to re-
duce the incidence of SSI after gastrointestinal surgery.
Sookhai et al. [8] conducted a randomized trial in which
the incidence of SSI after gastrointestinal surgery was
13.5% in the WEP group and 30% in the control group.
In their study, not only colorectal, but also other gastro-
intestinal surgery was included. In addition, there was a
difference in the body mass index (BMI) between West-
ern and Japanese people. On the other hand, the use of a
WEP is still controversial. Although several studies dem-
onstrated that a WEP reduced SSI in open surgery [9, 10],
contradicting results have also been reported [11]. There-
fore, a prospective cohort study with 2 parallel study
groups to investigate the incidence of SSI after colorectal
surgery in Japanese patients was conducted.
Methods
Trial Design
This study was a single-center, prospective cohort study with 2
parallel study groups. Enrolled patients were randomly assigned in
a 1:1 ratio. The Tokyo Medical and Dental University Ethics Com-
mittee approved this study (24–18). This study was also registered
with the University Hospital Medical Information Network
(UMIN000010289).
Participants
All patients who underwent elective open colorectal surgery
requiring a median laparotomy and colorectal resection were eli-
gible. Written, informed consent was obtained from patients
20 years or older before surgery. The planned operation was clas-
sified as clean-contaminated preoperatively according to the Cen-
ters for Disease Control and Prevention (CDC) definition [12].
Interventions
Only mechanical bowel preparation was performed preopera-
tively in this study. Povidone iodine was used for skin disinfection
before skin incision. The patients in the intervention group re-
ceived wound-edge coverage with a single-ring WEP (Steri-Drape,
3M, Saint Paul, MN, USA) immediately after laparotomy. Patients
in the control group had no coverage. The WEPs were removed
before closure of the fascia. In both groups, cefmetazole was admin-
istered 30 min before surgery and every 3 h during surgery. The
wound was lavaged by 1 L of saline before skin closure. The sur-
geons changed their gloves before closure of the abdominal wall.
Outcomes
The primary endpoint of this phase II trial was the incidence of
SSI (superficial, deep, organ-space) within 30 days after surgery.
Postoperative follow-up visits by an observer trained in the CDC
SSI definitions were performed at postoperative days 3, 7, 10, and
25–30. SSI was defined according to the CDC classification.
2 Dig Surg
DOI: 10.1159/000488214
Randomized
(n = 102)
Allocated to control Allocated to intervention
(n = 51) (n = 51)
No use of wound-edge
No laparotomy protection because of
(n = 1) severe adhesion
(n = 1)
Analyzed (n = 50) Analyzed (n = 50)
Fig. 1. Flowchart showing the categorization of participants.
Sample Size
The target sample size was set to be 50 in each arm to analyze
the effectiveness of a single-ring WEP in open colorectal surgery.
Randomization and Blinding
After confirming eligibility for participating in this study, the
patients were randomized to either with or without the use of a
WEP during the operation by the minimization method of balanc-
ing the 2 groups according to sex, BMI, tumor location, diabetes
mellitus, stoma, serum albumin, and history of laparotomy. Tu-
mor location was defined as follows: right-included cecum, as-
cending, and transverse colon; and left-included descending and
sigmoid colon, rectosigmoid, and rectum.
The patients were not told whether a WEP was used in their
operation until 30 days after surgery (single-blind study).
Statistical Analysis
All data are expressed as means ± SD. Differences in continu-
ous variables were compared using the Mann-Whitney U test,
while those in categorical variables were analyzed using the X2 test.
The independent risk factors for SSI were analyzed by logistic re-
gression analysis. Data were analyzed using JMP 9 (SAS Institute
Inc., Cary, NC, USA). Significance was established at p < 0.05.
Results
Participants
From October 2012 to August 2014, 102 patients were
enrolled; 51 patients were randomized to the intervention
group, and 51 patients were randomized to the control
group (Fig. 1). One patient in the control group was ex-
cluded because the laparotomy was changed to laparo-
scopic surgery at his request. One patient in the interven-
tion group was excluded because a WEP could not be
129.49.5.35 - 6/4/2018 7:38:23 PM
HSC Library-Serials Dept., SUNY
Kobayashi/Uetake/Yasuno/Sugihara
Downloaded by:
Table 1. Patients’ characteristics

Intervention group Control group p value

Gender
Male 29 29
Female 21 21 1
Age 69.5 68.5 0.74
BMI
≥25 13 12
<25 37 38 0.82
DM
Present 10 9
Absent 40 41 0.8
Malignancy
Present 48 46
Absent 2 4 0.4
Tumor site
Right 14 16
Left 36 34 0.66
Type of surgery
Right colectomy 14 16
Left colectomy 2 0
Sigmoidectomy 13 11
Anterior resection 11 11
Ultra-low anterior resection with ostomy 3 3
Abdomino-perineal resection 5 6
Total colectomy 1 1 0.83
Previous laparotomy
Present 17 18
Absent 33 32 0.83
Stoma
Present 9 12
Absent 41 38 0.46
Steroid
Present 2 2
Absent 48 48 1
Preoperative serum albumin
>3 43 45
≤3 7 5 0.54

BMI, body mass index; DM, diabetes mellitus.

used due to severe adhesions in the abdomen. Finally, 50 Table 2. Incidence of surgical site infection
patients in each group underwent further analysis.
There were no differences in clinical characteristics Total, n (%) Superficial Deep Organ
between the 2 groups (Table 1). Intervention group 8 (16) 8 (16) 0 0
Control group 18 (36) 14 (28) 2 (4) 2 (4)
Surgical Site Infections
Twenty-six patients had SSIs (26%) in this series. The
SSI rates in the intervention and control groups were 16 into organ SSIs. Older age (p = 0.0073) and no WEP (p =
and 36% respectively (p = 0.021). In the intervention 0.021) were risk factors for SSI after open surgery for
group, there was no deep or organ SSI. In contrast, in the colorectal disease on univariate analysis (Table 3). Multi-
control group, 4% of patients had deep and organ SSIs re- variate analysis showed that both older age (p = 0.016) and
spectively (Table 2). Two leaks were found and classified no WEP (p = 0.012) were independent risk factors for SSI.
129.49.5.35 - 6/4/2018 7:38:23 PM
HSC Library-Serials Dept., SUNY

Effectiveness of WEPs in Colorectal Dig Surg 3

Surgery DOI: 10.1159/000488214
Downloaded by:
Table 3. Association between surgical site infection and clinical factors

Univariate analysis Multivariate analysis

SSI (+) SSI (–) p value OR 95% CI p value

Gender
Male 15 (25.9) 43
Female 11 (26.2) 31 0.97
Age 75.5 66 0.0073 1
1.05 1.01–1.11 0.016
BMI
≥25 8 (32) 17
<25 18 (24) 57 0.44
DM
Present 3 (15.8) 16
Absent 23 (28.4) 58 0.24
Malignancy
Present 25 (26.6) 69
Absent 1 (16.7) 5 0.57
Stage
I 0 (0) 4
II 9 (29) 22
III 10 (32.3) 21
IV 6 (21.4) 22
Benign 1 (16.7) 5 0.44
Tumor site
Right 9 (30) 21
Left 17 (24.3) 53 0.55
Previous laparotomy
Present 9 (25.7) 26
Absent 17 (26.2) 48 0.96
Stoma
Present 4 (19.1) 17
Absent 22 (27.9) 57 0.4
Steroid
Present 0 4
Absent 26 (27.1) 70 0.12
Preoperative serum albumin
>3 22 (25) 66
≤3 4 (33.3) 8 0.55
Intervention
Present 8 (16) 42 1
Absent 18 (36) 32 0.021 3.37 1.30–9.52 0.012
Operation time, min 216 (87–546) 208 (87–588) 0.4
Blood loss, mL 325 (12–5,077) 310 (20–7,620) 0.77

SSI, surgical site infection; BMI, body mass index; DM, diabetes mellitus.

The median postoperative hospital stay was 15 (8–43) Discussion

and 11 (7–83) days in the patients with and without SSI
respectively (p = 0.044).
Harms
None of the patients died during their hospital stay in
this series. No adverse events caused by the intervention
were reported.
SSI is one of the major complications after surgery, but
no method to prevent SSI has been established.
A WEP has been used to prevent SSI after colorectal
surgery. Although several studies showed the usefulness
of WEPs, they included not only colorectal but also oth-
er types of gastrointestinal surgeries [8, 9, 11]. At the
129.49.5.35 - 6/4/2018 7:38:23 PM
HSC Library-Serials Dept., SUNY

4 Dig Surg Kobayashi/Uetake/Yasuno/Sugihara

DOI: 10.1159/000488214
Downloaded by:
same time, racial differences such as BMI should be tak-
en into consideration to interpret the results of clinical
trials.
Therefore, a prospective cohort study with 2 parallel
study groups to clarify the incidence of SSI after colorec-
tal surgery in Japanese patients was conducted. In the
present study, the incidence of SSI in patients with
and  without a WEP was 16 and 36% respectively. Al-
though this was not a phase III trial, there was a signifi-
cant difference in the incidence of SSI between the 2
groups.
The efficacy of WEPs for preventing SSI is still con-
troversial. The German double-blinded, randomized,
controlled trial, BaFO, demonstrated that the single-ring
WEP significantly reduced the incidence of SSI [9]. In
their study, the incidence of SSI in patients with and
without a WEP was 17.7 and 25.2% respectively (p =
0.026).
On the other hand, another recent study did not dem-
onstrate the efficacy of a single-ring WEP for preventing
SSI. The ROSSINI trial assigned 760 patients to 2 groups:
a WEP group and a non-WEP group [11]. There was no
difference in SSI incidence after gastrointestinal surgery,
and the SSI incidence in patients with and without a WEP
was 24.7 and 25.4% respectively. In the ROSSINI trial, the
incidence of SSI in patients with a WEP seemed higher
than that in the BaFO trial and the present trial. Both the
BaFO and ROSSINI trials included not only colorectal
surgery but also other types of digestive surgeries. Taking
into consideration the results of the present study, a ran-
domized, phase III trial would be warranted to investigate
the efficacy of WEP use for preventing SSIs after colorec-
tal surgery.
Edwards et al. [13] reported a meta-analysis of ran-
domized, controlled trials for decreasing SSIs after gas-
trointestinal and biliary tract surgery. In their meta-anal-
ysis, WEP use reduced SSI incidence after digestive sur-
gery, with a risk ratio of 0.55. However, there were some
problems in their meta-analysis. The meta-analysis in-
cluded 3 single-ring WEP studies and 3 dual-ring WEP
studies. In addition, each randomized trial in the meta-
analysis did not have a large number of patients.
There are some potential limitations in the present
study.
First, since the present study included only elective
surgery cases, the efficacy of WEP use for emergent
colorectal surgery was not clarified. The rate of contam-
inated surgery is usually higher in emergent cases than in
elective cases. In addition, it is difficult to obtain in-
formed consent in emergent surgery. Therefore, it is rea-
Effectiveness of WEPs in Colorectal
Surgery
sonable to use a WEP in emergent colorectal surgery at
this time.
Second, the patients in this study did not take pro-
phylactic oral antibiotics preoperatively. When this
study started, the preoperative administration of oral
antibiotics was not standard in our institution. There-
fore, only mechanical preparation was performed pre-
operatively in this study. One of the reasons for the high
incidence of SSI in patients without a WEP in the pres-
ent study might be the absence of preoperative oral
­antibiotic administration. In addition, no wound cover-
age was performed in the control group, while most
­hospitals use surgical towels. These multiple factors
might lead to the high incidence of SSI in the control
group.
Third, since the single-ring WEP was used in the pres-
ent study, the efficacy of dual-ring WEPs was not clari-
fied. There are 2 types of WEP: the single-ring type and
the dual-ring type. A single-ring WEP is generally much
cheaper than a dual-ring WEP. Therefore, the single-ring
WEP was used in the present study. A cost-benefit com-
parison between single-ring and dual-ring WEPs should
be performed in the future.
In conclusion, the present prospective cohort study
with 2 parallel study groups demonstrated a lower inci-
dence of SSI after colorectal surgery with a WEP. The
present study suggests the usefulness of WEPs in elective
colorectal surgery. However, this was a single-center pro-
spective study and was not a phase III trial with sample
size calculation. A randomized, phase III trial would be
warranted to clarify the usefulness of WEPs in elective
colorectal surgery.
References   1 Siegel R, Naishadham D, Jemal A: Cancer sta-
tistics, 2012. CA Cancer J Clin 2012;62:10–29.
  2 Kotake K, Honjo S, Sugihara K, et al: Changes
in colorectal cancer during a 20-year period:
an extended report from the multi-institu-
tional registry of large bowel cancer, Japan.
Dis Colon Rectum 2003; 46(10 suppl):S32–
S43.
  3 Muto T, Kotake K, Koyama Y: Colorectal can-
cer statistics in Japan: data from JSCCR regis-
tration, 1974–1993. Int J Clin Oncol 2001; 6:
171–176.
 4 Reid K, Pockney P, Draganic B, Smith SR:
Barrier wound protection decreases surgical
site infection in open elective colorectal sur-
gery: a randomized clinical trial. Dis Colon
Rectum 2010;53:1374–1380.
  5 Song F, Glenny AM: Antimicrobial prophy-
laxis in colorectal surgery: a systematic review
of randomised controlled trials. Health Tech-
nol Assess 1998;2:1–110.
129.49.5.35 - 6/4/2018 7:38:23 PM
HSC Library-Serials Dept., SUNY
Dig Surg 5
DOI: 10.1159/000488214
Downloaded by:
  6 Tanner J, Khan D, Aplin C, Ball J, Thomas M,
Bankart J: Post-discharge surveillance to iden-
tify colorectal surgical site infection rates and
related costs. J Hosp Infect 2009;72:243–250.
  7 Coello R, Charlett A, Wilson J, Ward V, Pear-
son A, Borriello P: Adverse impact of surgical
site infections in English hospitals. J Hosp In-
fect 2005;60:93–103.
  8 Sookhai S, Redmond HP, Deasy JM: Impervi-
ous wound-edge protector to reduce postop-
erative wound infection: a randomised, con-
trolled trial. Lancet 1999;353:1585.
 9 Mihaljevic AL, Schirren R, Ozer M, et al:
Multicenter double-blinded randomized
6 Dig Surg
DOI: 10.1159/000488214
controlled trial of standard abdominal
wound edge protection with surgical dress-
ings versus coverage with a sterile circular
polyethylene drape for prevention of surgical
site infections: a CHIR-Net trial (BaFO;
NCT01181206). Ann Surg 2014; 260: 730–
737; discussion 7–9.
10 Mihaljevic AL, Muller TC, Kehl V, Friess H,
Kleeff J: Wound edge protectors in open ab-
dominal surgery to reduce surgical site infec-
tions: a systematic review and meta-analysis.
PLoS One 2015;10:e0121187.
11 Pinkney TD, Calvert M, Bartlett DC, et al: Im-
pact of wound edge protection devices on sur-
gical site infection after laparotomy: multi-
centre randomised controlled trial (ROSSINI
Trial). BMJ 2013;347:f4305.
12 Mangram AJ, Horan TC, Pearson ML, Silver
LC, Jarvis WR: Guideline for prevention of
surgical site infection, 1999. Hospital infec-
tion control practices advisory committee. In-
fect Control Hosp Epidemiol 1999; 20: 250–
278; quiz 79–80.
13 Edwards JP, Ho AL, Tee MC, Dixon E, Ball
CG: Wound protectors reduce surgical
site  infection: a meta-analysis of random-
ized controlled trials. Ann Surg 2012; 256:
53–59.
129.49.5.35 - 6/4/2018 7:38:23 PM
HSC Library-Serials Dept., SUNY
Kobayashi/Uetake/Yasuno/Sugihara
Downloaded by: