Research

JAMA Surgery | Original Investigation

Plastic Wound Protector vs Surgical Gauze for Surgical Site

Infection Reduction in Open GI Surgery
A Randomized Clinical Trial
Nina Yoo, MD, PhD; Ji Yeon Mun, MD; Bong-Hyeon Kye, MD, PhD; Chang Woo Kim, MD, PhD; Jae Im Lee, MD, PhD;
Youn Young Park, MD, PhD; Byung Mo Kang, MD, PhD; Byung Kwan Park, MD; Han Deok Kwak, MD, PhD;
Won-Kyung Kang, MD, PhD; Sung Uk Bae, MD, PhD; Heung-Kwon Oh, MD, PhD; Youngki Hong, MD; Hyung Jin Kim, MD, PhD

Visual Abstract
IMPORTANCE Surgical site infections (SSIs) are prevalent hospital-acquired infections with Invited Commentary
significant patient impacts and global health care burdens. The World Health Organization
recommends using wound protector devices in abdominal surgery as a preventive measure Supplemental content

to lower the risk of SSIs despite limited evidence.

OBJECTIVE To examine the efficacy of a dual-ring, plastic wound protector in lowering

the SSI rate in open gastrointestinal (GI) surgery irrespective of intra-abdominal
contamination levels.

DESIGN, SETTING, AND PARTICIPANTS This multicenter, patient-blinded, parallel-arm

randomized clinical trial was conducted from August 2017 to October 2022 at 13 hospitals
in an academic setting. Patients undergoing open abdominal bowel surgery (eg, for bowel
perforation) were eligible for inclusion.

INTERVENTION Patients were randomized 1:1 to a dual-ring, plastic wound protector to

protect the incision site of the abdominal wall (experimental group) or a conventional
surgical gauze (control group).

MAIN OUTCOMES AND MEASURES The primary end point was the rate of SSI within 30 days
of open GI surgery.

RESULTS A total of 458 patients were randomized; after 1 was excluded from the control
group, 457 were included in the intention-to-treat analysis (mean [SD] age, 58.4 [12.1] years;
256 [56.0%] male; 341 [74.6%] with a clean-contaminated wound): 229 in the wound
protector group and 228 in the surgical gauze group. The overall SSI rate in the
intention-to-treat analysis was 15.7% (72 of 458 patients). The SSI rate for the wound
protector was 10.9% (25 of 229 patients) compared with 20.5% (47 of 229 patients) with
surgical gauze. The wound protector significantly reduced the risk of SSI, with a relative risk
reduction (RRR) of 46.81% (95% CI, 16.64%-66.06%). The wound protector significantly
decreased the SSI rate for clean-contaminated wounds (RRR, 43.75%; 95% CI,
3.75%-67.13%), particularly for superficial SSIs (RRR, 42.50%; 95% CI, 7.16%-64.39%).
Length of hospital stay was similar in both groups (mean [SD], 15.2 [10.5] vs 15.3 [10.2] days),
as were the overall postoperative complication rates (20.1% vs 18.8%).

CONCLUSIONS AND RELEVANCE This randomized clinical trial found a significant reduction
in SSI rates when a plastic wound protector was used during open GI surgery compared
with surgical gaze, supporting the World Health Organization recommendation for use
of wound protector devices in abdominal surgery.

TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03170843

Author Affiliations: Author

affiliations are listed at the end of this
article.
Corresponding Author:
Hyung Jin Kim, MD, PhD,
Department of Surgery, EunPyeong
St Mary’s Hospital, The Catholic
JAMA Surg. doi:10.1001/jamasurg.2024.0765 University of Korea, Seoul, Korea
Published online April 24, 2024. ([email protected]).

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 Research Original Investigation Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery

S
urgical site infection (SSI) is a common postoperative
complication in patients undergoing general abdomi- Key Points
nal surgery. It is associated with a significant burden for
Question Does a plastic wound protector lower surgical site
health care practitioners and patients, with extra medical ex- infection (SSI) rates compared with surgical gauze in open
penses, time, and human resources.1 Global guidelines and gastrointestinal surgeries?
recommendations for preventing SSI suggest regulating risk
Findings In this randomized clinical trial of 458 patients,
factors and applying preventive measures in the preopera-
the wound protector decreased SSI risk by 46.8% across bowel
tive, intraoperative, and postoperative periods.2-4 To provide surgeries, with a 43.8% decrease for clean-contaminated wounds
uniform and clear instructions on SSI prevention, the World and 42.5% for superficial SSIs, compared with surgical gauze.
Health Organization (WHO) developed evidence-based rec- Its effect on contaminated wounds was less certain.
ommendations for preoperative, intraoperative, and postop-
Meaning Plastic wound protectors are effective in reducing SSIs
erative periods.5,6 In the intraoperative period, the use of a in open gastrointestinal surgeries.
wound protector device is recommended to reduce the rate of
SSI in clean-contaminated, contaminated, and dirty abdomi-
nal surgical procedures.6 Participants
However, the WHO panel6 suggested its use with condi- Patients undergoing open abdominal GI surgery were eligible
tional recommendation with a very low quality of evidence. for inclusion. Inclusion criteria were the following: (1) age of
A meta-analysis based on 10 randomized clinical trials and 1 18 to 75 years, (2) undergoing elective or emergent open ab-
prospective clinical trial indicated that use of a wound pro- dominal surgery, and (3) undergoing surgery on the stomach,
tector device was associated with a lower risk of SSI com- small intestine, or colon and rectum. Patients were excluded
pared with conventional wound protection (odds ratio, 0.42; if they exhibited any of the following: (1) presence of concur-
95% CI, 0.28-0.62).6 However, the studies included in the rent infection in the abdominal wall; (2) open conversion
meta-analysis consisted of a heterogeneous population, from laparoscopic surgery; (3) presence of poor nutritional sta-
such as patients undergoing cesarean delivery, those with tus, indicated by a Nutritional Risk Screening9 2002 score of
fecal peritonitis, or those with hepatobiliary surgery. More- 3 or greater; (4) undergoing combined hepatobiliopancreatic
over, data on patients who present with contaminated or surgery; (5) pregnancy or breastfeeding; and (6) moderate to
dirty wounds are scarce. Therefore, the effectiveness of severe immunosuppression state, defined as previous organ
reducing SSI for surgical procedures dealing with contami- or bone marrow transplant, concurrent corticosteroid admin-
nated or dirty wounds has not been shown, to our knowl- istration (>10 mg prednisolone daily or an equivalent dose of
edge. Additional data with a comparable study population any other corticosteroid), or concurrent administration of other
and control of various confounding factors are necessary to immunosuppressive or chemotherapeutic agents within the
provide strong evidence supporting the recommendation. 2 weeks before trial intervention.
Therefore, to provide high-quality evidence, this study
evaluated the effectiveness of a plastic wound protector in Surgical Interventions
reducing the rate of SSI for patients undergoing open An open laparotomy was made once a patient was adminis-
abdominal gastrointestinal (GI) surgery. tered general anesthesia. A dual-ring wound protector (O Trac;
Asung Medical Inc) was applied to the incision site in the pa-
tients in the experimental group (eFigure 1 in Supplement 2).
The patients in the control group had their incision site cov-
Methods ered with conventional surgical gauze (eFigure 2 in Supple-
Study Design and Participating Centers ment 2). The wound protector and the surgical gauze were left
This patient-blinded, multicentered, randomized clinical in situ during the entire operation and immediately removed
trial compared a protective plastic dual-ring wound retractor just before closing the abdominal wall. The details of preop-
with conventional surgical gauze for incisional wound pro- erative, intraoperative surgical, and postoperative procedures
tection in open abdominal GI surgery (NCT03170843; trial followed the policy of an individual surgeon and institutional
protocol in Supplement 1). From August 2017 to October 2022, infection control policy at each center. Board-certified gen-
this study was conducted and analyzed following the eral surgeons performed all surgical procedures in an aca-
Consolidated Standards of Reporting Trials (CONSORT) demic setting.
guideline.7 The study protocol was publicly opened after All investigators were mandated to adhere to the SSI pre-
trial initiation for further recruitment and to assist participating vention bundle, particularly for elective colorectal surgeries.6,10
investigators and study coordinators in conducting the This comprehensive protocol includes mechanical bowel
study as planned.8 A total of 13 referral hospitals in an academic preparation, prophylactic antibiotic administration, surgical
setting in South Korea participated. There have been no field antisepsis, and the maintenance of intraoperative nor-
major changes to the trial methods since the beginning. mothermia. All participating centers used disposable surgi-
The institutional review board at each participating center cal gloves and gowns. However, the replacement of surgical
reviewed the trial protocol and informed consent document and gowns and gloves was at the discretion of the operating sur-
granted ethical approval. All participants provided written geon. Wound irrigation was performed using normal saline
informed consent. rather than an antibiotic solution. Additionally, no specific

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 Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery Original Investigation Research

wound dressing type was mandated; selection was based on to 5%, a total of 458 patients, 229 patients in each group, were
each investigator’s preference. anticipated to participate in the study.

Study Outcomes Randomization and Blinding

The primary outcome was the difference in rates of SSIs be- Patients were enrolled by treating surgeons or permitted re-
tween 2 groups: one using the plastic wound protector (ex- search personnel. A biostatistician predefined the group allo-
perimental group) and the other using conventional surgical cation and randomization sequence. Patients were random-
gauze (control group). Surgical site infections were defined by ized 1:1 to the experimental or control group. A permuted block
the diagnostic criteria suggested by the US Centers for Dis- randomization with the size of 2 or 4 was applied. On the suc-
ease Control and Prevention within 30 days after surgery cessful screening, the patient was stratified according to the
and classified as superficial incisional, deep incisional, and or- anticipated category of wound contamination, with 2 sepa-
gan or space.11 The secondary outcome was to compare the rately powered strata: one with clean contaminated wounds
length of postoperative hospital stay and the rate of surgical and the other with contaminated or dirty infected wounds. A
complications other than SSI in the 2 groups. The postopera- web-based patient registry13 was used to allocate each pa-
tive surgical complications were classified according to the tient before the beginning of the operation, which provided
modified Clavien-Dindo classification.12 Other secondary adequate concealment for the allocation sequence. Although
outcomes included the hospital readmission rate; however, participating surgeons were not blinded to the allocated treat-
patients diagnosed with a malignant disease after surgery re- ment, the patients were blinded to the trial intervention. Once
quired readmission for chemotherapy postoperatively. There- a patient was identified and agreed to participate in the trial,
fore, the hospital readmission rate was not counted as the the patient was screened for fitness to participate. The data
secondary outcome. manager was also blinded due to a lack of access to the trial
intervention and the randomization.
Data Collection
A web-based electronic case reporting form (eCRF) was used Statistical Analysis
to record data on the patients.13 Patient baseline characteris- The statistical analysis was performed by an independent
tics, the parameters for the surgical procedure, and the peri- statistician from The Catholic Medical Center (Seoul, South
operative laboratory parameters were reported in a timely Korea). The result was analyzed for the intention-to-treat (ITT)
manner (detailed parameters are given in Supplement 1). population and the per-protocol (PP) population. The rate of
Each surgeon responsible for enrolled patients evaluated the 30-day postoperative SSI was evaluated in all patients and ana-
patient’s surgical wound at postoperative weeks 1, 2 to 3, and lyzed according to the wound classification: superficial inci-
4 to 5. In cases in which patients did not adhere to office vis- sional, deep incisional, and organ or space SSIs. Pearson χ2
its, a telephone interview was conducted to identify any test or Fisher exact test was used to analyze nominal data.
symptoms or signs of infection or inflammation in the surgi- The t test and the Wilcoxon rank sum test were used for con-
cal site. A photograph of the wound was taken at each office tinuous variables. P values were also calculated from the Coch-
visit and uploaded in the eCRF. If SSI was detected, its classi- ran-Mantel-Haenszel test, stratified by wound type, the ran-
fication and the postoperative date of diagnosis were domization stratification factor. The difference was constructed
recorded. Confirmation of SSI was made using the photo- for the control minus the wound protector group, and the
graph by 2 others who were not involved in the clinical 95% CIs were constructed using the Wald method. Sensitiv-
trial. Postoperative complications categorized by the ity analysis was performed for participants with organ-space
modified Clavien-Dindo classification and postoperative infection who were excluded from the trial. The statistical
length of hospital stay were documented. All the data were analysis was conducted using SAS, version 9.4 (SAS Institute
entered in the eCRF by an investigator or research coordina- Inc). Two-sided P < .05 was considered significant.
tor at each center.

Power Calculation
This clinical trial investigated the superiority of a plastic wound
Results
retractor in reducing the rate of SSIs compared with a conven- From August 2017 to October 2022, 458 patients were en-
tional surgical gauze. Initially, the ratio of operations with clean rolled and randomly assigned to the experimental group or the
or clean-contaminated, contaminated, and dirty infected control group (Figure). Initially, 229 patients were allocated to
wounds was estimated to be 20%:40%:40% based on a re- each group as the ITT population. However, after randomiza-
view of published data14-18 and our experience. As the SSI in- tion, 1 patient in the control group was found to have violated
cidence was reported as 10% for clean or clean-contami- a screening protocol, leading to an ITT population of 457 pa-
nated, 25% for contaminated, and 40% for dirty infected tients (201 [44.0%] female and 256 [56.0%] male): 229 in the
wounds, the incidence of SSI for the control group was 28%, wound protector group and 228 in the control group. The mean
and the incidence of SSI was expected to be reduced by a range (SD) age was 58.4 (12.1) years, with a median age of 60.0 years
of 17% to 40% in the experimental group.14-18 A sample size (IQR, 52.0-68.0 years). Subsequently, 19 patients from the
of 434 participants was determined to achieve a study power wound protector group and 26 patients from the control group
of 80% with 2-sided 95% CIs. Considering a dropout rate up were excluded from the study, leaving 210 and 202 patients

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 Research Original Investigation Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery

Figure. CONSORT Flowchart

458 Enrolled

458 Randomized

229 Randomized to the experimental group using the 229 Randomized to the control group using the
plastic wound protector conventional surgical gauze

4 Lost to follow-up
8 Lost to follow-up
22 Discontinued intervention
11 Discontinued intervention
4 Withdrawal of informed consent
4 Withdrawal of informed consent
7 Deceased before study completion
4 Deceased before study completion
11 Protocol violation due to screening failure
3 Protocol violation due to screening failure
4 Laparoscopic attempt
1 Laparoscopic attempt
3 Combined hepatobiliopancreatic surgery
1 Combined hepatobiliopancreatic surgery
1 Combined cystectomy
1 Moderate-to-severe immunosuppression state
3 Moderate-to-severe immunosuppression state

229 Included in ITT analysis 228 Included in ITT analysis

210 Included in per-protocol analysis 1 Excluded (NRS score >3 at screening)
202 Included in per-protocol analysis
ITT indicates intention-to-treat;
NRS, Nutritional Risk Screening.

in the PP analysis for the experimental and control groups, re- 64.39%). Subgroup analysis showed consistent efficacy of the
spectively. The reasons for these exclusions are detailed in the wound protector in reducing superficial SSIs compared with
CONSORT diagram (Figure). conventional gauze. Sensitivity analysis also indicated a sig-
Table 1 shows the baseline characteristics of patients in the nificant reduction in superficial SSIs with the wound protec-
ITT and PP populations. In a total of 457 patients, 341 (74.6%) tor (eTable 1 in Supplement 2). No significant difference was
had a clean-contaminated wound, with the remaining 116 observed in the length of postoperative hospital stay be-
(25.4%) having a contaminated or dirty infected wound. Over- tween the groups, with a mean (SD) of 15.2 (10.5) days for the
all, there was no significant difference between the 2 groups wound protector group and 15.3 (10.2) days for the control
except in the PP analysis, in which body mass index (calcu- group (P = .69). Postoperative complications occurred in 89 of
lated as weight in kilograms divided by height in meters 458 patients (19.4%), with no significant difference between
squared) was slightly higher in the control group than in the the groups: 46 of 229 (20.1%) in the wound protector group
wound protector group (mean [SD], 23.8 [3.8] vs 23.0 [3.6]; vs 43 of 229 (18.8%) in the control group (P = .41). The Clavien-
P = .04). Dindo classification indicated a similar severity distribution
Table 2 outlines the preoperative and intraoperative char- of postoperative morbidity in both groups (eTable 2 in Supple-
acteristics, including interventions. Emergency surgeries ment 2).
accounted for 161 (36.7%) in the ITT population and 153 (37.1%)
in the PP population. The most common surgical site was the
colorectum (324 patients [70.9%] in the ITT population and
296 [71.8%] in the PP population). Contaminated or dirty in-
Discussion
fected wounds were present in 124 (27.1%) in the ITT popula- This randomized clinical trial found that using a plastic wound
tion and 117 (28.4%) in the PP population. Preoperative and sur- protector during open abdominal GI surgery reduced the oc-
gical factors were largely comparable between the groups. currence of SSI by 46.81% compared with using conventional
Notably, in the PP group, the control group’s incision length surgical gauze. This is consistent with previous research that
was significantly longer than that in the wound protector group showed a reduced odds of SSI associated with the use of a dual-
(mean [SD], 20.3 [5.8] vs 19.1 [5.1] cm; P = .03). ring wound protector (odds ratio, 0.44; 95% CI, 0.35-0.56).19
Table 3 displays the SSI rates. The rate was 10.9% (25 of Subgroup analyses further confirmed the consistent risk-
229 patients) for the wound protector group and 20.5% (47 of reduction effect of the wound protector for both clean-
229 patients) for the control group, with an overall rate of 15.7% contaminated and contaminated wounds. Overall, the evi-
(72 of 458 patients). The wound protector achieved a statisti- dence from this study robustly supports the efficacy of plastic
cally significant 46.81% relative risk reduction (95% CI, 16.64%- wound protectors in preventing postoperative SSIs by shield-
66.06%; P = .005). The wound protector significantly de- ing the incision site from bacterial contamination.
creased the SSI rate for clean-contaminated wounds (relative The overall SSI rate observed in this study was 15.7%, align-
risk reduction, 43.75%; 95% CI, 3.75%-67.13%), particularly for ing with prior reports of SSI incidence for bowel, colon, and
superficial SSIs (relative risk reduction, 42.50%; 95% CI, 7.16%- rectum procedures.20 This rate is within the expected 14% to

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 Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery Original Investigation Research

Table 1. Baseline Patient Characteristicsa

Intention-to-treat population Per-protocol population

Wound protector Wound protector
Characteristic Total (n = 457) (n = 229) Gauze (n = 228) Total (n = 412) (n = 210) Gauze (n = 202)
Wound type
Clean-contaminated 341 (74.6) 171 (74.7) 170 (74.6) 306 (74.3) 155 (73.8) 151 (74.8)
Contaminated or dirty, infected 116 (25.4) 58 (25.3) 58 (25.4) 106 (25.7) 55 (26.2) 51 (25.2)
Sex
Female 201 (44.0) 100 (43.7) 101 (44.3) 185 (44.9) 92 (43.8) 93 (46.0)
Male 256 (56.0) 129 (56.3) 127 (55.7) 227 (55.1) 118 (56.2) 109 (54.0)
Age, y
Mean (SD) 58.4 (12.1) 58.4 (12.2) 58.3 (12.0) 58.2 (12.1) 58.5 (12.2) 58.0 (12.1)
Median (IQR) 60.0 (52.0-68.0) 60.0 (52.0-68.0) 60.0 (52.0-67.5) 60.0 (52.0-68.0) 60.0 (52.0-68.0) 60.0 (51.0-67.0)
Age-adjusted preoperative
NRS-2002 scoreb
0 235 (51.4) 116 (50.7) 119 (52.2) 213 (51.7) 106 (50.5) 107 (53.0)
1 111 (24.3) 61 (26.6) 50 (21.9) 99 (24.0) 55 (26.2) 44 (21.8)
2 111 (24.3) 52 (22.7) 59 (25.9) 100 (24.3) 49 (23.3) 51 (25.2)
BMI
Mean (SD) 23.3 (3.7) 23.0 (3.6) 23.6 (3.8) 23.4 (3.8) 23.0 (3.6) 23.8 (3.8)
Median (IQR) 23.1 (20.7-25.3) 22.7 (20.5-25.1) 23.5 (21.3-25.6) 23.2 (20.8-25.4) 22.7 (20.5-25.1) 23.6 (21.5-25.6)
ASA class
I or II 374 (81.8) 186 (81.2) 188 (82.5) 350 (85.0) 177 (84.3) 173 (85.6)
III or IV 75 (16.4) 39 (17.0) 36 (15.8) 62 (15.0) 33 (15.7) 29 (14.4)
History of diabetes
Yes 80 (17.5) 41 (17.9) 39 (17.1) 72 (17.5) 37 (17.6) 35 (17.3)
No 369 (80.7) 184 (80.3) 185 (81.1) 340 (82.5) 173 (82.4) 167 (82.7)
Smoking habit
Yes 67 (14.7) 36 (15.7) 31 (13.6) 55 (13.3) 31 (14.8) 24 (11.9)
No 382 (83.6) 189 (82.5) 193 (84.6) 357 (86.7) 179 (85.2) 178 (88.1)
Alcohol consumption
Yes 110 (24.1) 58 (25.3) 52 (22.8) 99 (24.0) 53 (25.2) 46 (22.8)
No 339 (74.2) 167 (72.9) 172 (75.4) 313 (76.0) 157 (74.8) 156 (77.2)
Necessity of postoperative ICU care
Yes 50 (10.9) 23 (10.0) 27 (11.8) 45 (10.9) 22 (10.5) 23 (11.4)
No 399 (87.3) 202 (88.2) 197 (86.4) 367 (89.1) 188 (89.5) 179 (88.6)
History of chemotherapy
Yes 91 (19.9) 45 (19.7) 46 (20.2) 86 (20.9) 44 (21.0) 42 (20.8)
No 358 (78.3) 180 (78.6) 178 (78.1) 326 (79.1) 166 (79.0) 160 (79.2)
History of radiotherapy
Yes 30 (6.6) 16 (7.0) 14 (6.1) 27 (6.6) 16 (7.6) 11 (5.4)
No 419 (91.7) 209 (91.3) 210 (92.1) 385 (93.4) 194 (92.4) 191 (94.6)
History of abdominal surgery
Yes 205 (44.9) 101 (44.1) 104 (45.6) 194 (47.1) 97 (46.2) 97 (48.0)
No 244 (53.4) 124 (54.1) 120 (52.6) 218 (52.9) 113 (53.8) 105 (52.0)
Corticosteroid use
Yes 9 (2.0) 2 (0.9) 7 (3.1) 7 (1.7) 2 (1.0) 5 (2.5)
No 440 (96.3) 223 (97.4) 217 (95.2) 405 (98.3) 208 (99.0) 197 (97.5)
Immunosuppressant use
Yes 5 (1.1) 3 (1.3) 2 (0.9) 5 (1.2) 3 (1.4) 2 (1.0)
No 444 (97.2) 222 (96.9) 222 (97.4) 407 (98.8) 207 (98.6) 200 (99.0)
Antiplatelet or anticoagulant use
Yes 30 (6.6) 16 (7.1) 14 (6.1) 26 (6.3) 15 (7.1) 11 (5.4)
No 419 (91.7) 209 (91.3) 210 (92.1) 386 (93.7) 195 (92.9) 191 (94.6)

(continued)

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 Research Original Investigation Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery

Table 1. Baseline Patient Characteristicsa (continued)

Intention-to-treat population Per-protocol population

Wound protector Wound protector
Characteristic Total (n = 457) (n = 229) Gauze (n = 228) Total (n = 412) (n = 210) Gauze (n = 202)
GI cancer history
Yes 108 (23.6) 56 (24.5) 52 (22.8) 98 (23.8) 53 (25.2) 45 (22.3)
No 341 (74.6) 169 (73.8) 172 (75.4) 314 (76.2) 157 (74.8) 157 (77.7)
b
Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index A score of 0 indicates a normal nutritional status; 1, mild impairment of
(calculated as weight in kilograms divided by height in meters squared); nutritional status; and 2, moderate impairment of nutritional status.
GI,gastrointestinal;ICU,intensivecareunit;NRS-2002,NutritionalRiskScreening2002.
a
Data are given as number (percentage) of patients, unless otherwise indicated.

25% range for SSIs in open laparotomy for colon surgery and In this study, the incidence of deep wound infections
is consistent with the increase in SSI rates to 28% when con- was comparable between the 2 groups, with rates of 1.3%
tamination is present.21,22 Notably, the SSI rate in the wound and 1.7%, respectively. Deep wound infections, unlike super-
protector group was 10.9%, which was half the rate in the con- ficial SSIs that stem from exudate in the subcutaneous
trol group using gauze. The substantial decrease in SSIs can space, involve the fascial and muscle layers, which are typi-
also be credited to the meticulous application and obser- cally closed during surgery to prevent evisceration, barring
vance of preventive practices, such as skin preparation, pro- situations like acute compartment syndrome. At the sur-
phylactic antibiotic use, and maintenance of normothermia. geon’s discretion, a closed drainage system was imple-
Based on literature on multiple risk factor analysis and mented selectively to control exudate and potentially lower
preventive measures lowering SSI rates,1,10 guidelines for SSI the risk of deep infections. However, factors beyond bacte-
prevention have been formulated and are broadly imple- rial contamination also played a role; the healing of deep fas-
mented by medical facilities and staff.3-6,23 In Korea, the cial wounds is contingent on maintaining adequate tension,
Korean Nosocomial Infections Surveillance System, initiated blood flow, and oxygenation.36 Consequently, the develop-
in 2006, has been instrumental in promoting the adoption of ment of deep wound infections is a multifaceted issue
these SSI prevention strategies.24 Additionally, the Korean dependent on bacterial load, mechanical stress, and tissue
Disease Control and Prevention Agency and the Korean Sur- perfusion. While a wound protector can limit bacterial con-
gical Infection Society provide ongoing education on these tact with the wound, effectively preventing deep infections
protocols.25 It is reasonable to consider that such initiatives, also necessitates enhancing overall patient condition to
coupled with the use of a wound protector acting as a physi- ensure optimal tissue healing.
cal barrier to bacterial contamination, could markedly de-
crease the rate of superficial SSIs. Strengths and Limitations
In addition to wound protection, a plastic wound protec- A strength of this study is that the controlled factors included
tor also enhances surgical field visibility by retracting the in- preoperative nutritional status and wound class. Before en-
cision site. Despite the rise of minimally invasive techniques rollment, each patient was assessed for nutritional status along
that contribute to the reduction of SSI,26-28 many patients still with preoperative medical conditions that might interfere with
require open GI surgery.29 A self-retaining plastic wound re- the wound healing process. By controlling crucial factors as-
tractor, designed for smaller incisions but wider operative sociated with postoperative SSI development, we could inves-
views, was shown to significantly shorten incision lengths in tigate the dominant effect of a plastic wound protector on SSI
2 studies.30,31 Thus, the plastic wound protector not only serves risk. Another strength is that the study population included
as a physical barrier against postoperative SSIs but also may patients in an emergency setting with purulent or fecal peri-
aid surgeons by functioning as an intraoperative retractor. tonitis. Including only bowel surgery, this study solely evalu-
As expected, a plastic wound protector could not prevent ated the effect of a wound protector on lowering the SSI risk
the deep wound or organ-space infections in this study. A pa- particularly for colorectal surgery.
tient who had upper GI surgery developed an abscess in the This study has limitations that should be addressed. First,
retroperitoneum, while 3 patients who underwent colorectal the study did not identify the readmission rate for SSI, mak-
procedures experienced anastomotic leaks. Anastomotic leak- ing it difficult to accurately estimate cost-effectiveness. How-
age is largely influenced by tension, blood supply, and bacte- ever, a postdischarge surveillance program using telephone
rial infection.32-34 Ischemia in the site of surgery can also calls was implemented to closely monitor patients and re-
contribute to or worsen intraperitoneal abscesses.35 There- duce missed diagnoses of SSI, ensuring reliable data on the SSI
fore, patient factors, such as hemodynamic stability or de- rate. Second, the cost-effectiveness of a plastic wound pro-
gree of contamination, may be associated with the develop- tector is challenging to speculate. While it effectively func-
ment of organ-space infection. Thoroughly washing the tions as a retractor and reduces the SSI rate, its environmen-
contaminated abdomen may help in reducing the chances tal impact and resource consumption have not been
of intra-abdominal abscesses. Fundamentally, due to the com- investigated. Plastic wound protectors contribute to medical
plex nature of factors contributing to organ-space infection, waste and environmental degradation. Developing a biode-
it is beyond the control of a plastic wound protector. gradable alternative may be ideal but could be costlier and

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 Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery Original Investigation Research

Table 2. Preoperative and Intraoperative Characteristicsa

Intention-to-treat population Per-protocol population

Wound protector Wound protector
Characteristic Total (n = 457) (n = 229) Gauze (n = 228) Total (n = 412) (n = 210) Gauze (n = 202)
Surgery timing
Elective 285 (62.4) 140 (61.1) 145 (63.6) 259 (62.9) 130 (61.9) 129 (63.9)
Emergency 161 (35.2) 84 (36.7) 77 (33.8) 153 (37.1) 80 (38.1) 73 (36.1)
Surgical site
Stomach 14 (3.1) 4 (1.7) 10 (4.4) 12 (2.9) 3 (1.4) 9 (4.5)
Small bowel 108 (23.6) 54 (23.6) 54 (23.7) 104 (25.2) 52 (24.8) 52 (25.7)
Colorectal 324 (70.9) 166 (72.5) 158 (69.3) 296 (71.8) 155 (73.8) 141 (69.8)
Trauma-related surgery
Yes 7 (1.5) 3 (1.3) 4 (1.8) 259 (62.9) 130 (61.9) 129 (63.9)
No 439 (96.1) 221 (96.5) 218 (95.6) 153 (37.1) 80 (38.1) 73 (36.1)
Type of skin preparation
Ethanol 6 (1.3) 3 (1.3) 3 (1.3) 5 (1.5) 3 (1.8) 2 (1.3)
Isopropyl alcohol 2 (0.4) 1 (0.4) 1 (0.4) 2 (0.6) 1 (0.6) 1 (0.7)
Aqueous povidone 259 (56.7) 139 (60.7) 120 (52.6) 242 (74.7) 132 (77.2) 110 (71.9)
Chlorohexidine 64 (14.0) 34 (14.8) 30 (13.2) 57 (17.6) 28 (16.4) 29 (19.0)
>2 Substances 18 (3.9) 7 (3.1) 11 (4.8) 18 (5.6) 7 (4.1) 11 (7.2)
Degree of intraperitoneal
contamination
Clean-contaminated 322 (70.5) 164 (71.6) 158 (69.3) 295 (71.6) 153 (72.9) 142 (70.3)
Contaminated or dirty, 124 (27.1) 60 (26.2) 64 (28.1) 117 (28.4) 57 (27.1) 60 (29.7)
infected
Use of antibiotics
Therapeutic 233 (50.8) 118 (51.5) 115 (50.4) 219 (53.2) 111 (52.9) 108 (53.5)
Prophylactic 212 (46.4) 106 (46.3) 106 (46.5) 193 (46.8) 99 (47.1) 94 (46.5)
Total surgery time, min
Mean (SD) 169.2 (88.0) 168.7 (86.5) 169.7 (89.7) 170.0 (88.2) 170.0 (87.7) 170.0 (88.9)
Median (IQR) 150.0 145.0 153.0 150.0 145.5 154.5
(107.0-210.0) (110.0-207.5) (105.0-215.0) (105.5-215.0) (110.0-210.0) (105.0-215.0)
Bowel anastomosis
Yes 356 (77.9) 180 (78.6) 176 (77.2) 329 (79.9) 169 (80.5) 160 (79.2)
No 90 (19.7) 44 (19.2) 46 (20.2) 83 (20.1) 41 (19.5) 42 (20.8)
Colostomy formation
Yes 82 (17.9) 41 (17.9) 41 (18.0) 75 (18.2) 38 (18.1) 37 (18.3)
No 364 (79.6) 183 (79.9) 181 (79.4) 337 (81.8) 172 (81.9) 165 (81.7)
Skin suture material
Nylon 102 (22.3) 48 (21.0) 54 (23.7) 89 (21.6) 42 (20.0) 47 (23.3)
Vicryl 22 (4.8) 14 (6.1) 8 (3.5) 20 (4.9) 13 (6.2) 7 (3.5)
Skin stapler 240 (52.5) 124 (54.1) 116 (50.9) 230 (55.8) 121 (57.6) 109 (54.0)
>2 Substances 82 (17.9) 38 (16.6) 44 (19.8) 73 (17.7) 34 (16.2) 39 (19.3)
Incision length, cm
Mean (SD) 19.7 (5.4) 19.2 (5.0) 20.3 (5.7) 19.7 (5.4) 19.1 (5.1) 20.3 (5.8)
Median (IQR) 20.0 (16.0-22.5) 19.0 (16.0-22.0) 20.0 (17.0-23.0) 20.0 (16.0-22.0) 19.0 (16.0-22.0) 20.0 (17.0-23.0)
Use of drainage system on
the superficial wound
Yes 145 (31.7) 76 (33.2) 69 (30.3) 136 (33.0) 71 (33.8) 65 (32.2)
No 301 (65.9) 148 (64.6) 153 (67.1) 276 (67.0) 139 (66.2) 137 (67.8)
Body temperature
during surgery, °C
Mean (SD) 36.4 (0.6) 36.4 (0.6) 36.4 (0.5) 36.4 (0.5) 36.4 (0.6) 36.4 (0.5)
Median (IQR) 36.4 (36.1-36.7) 36.3 (36.1-36.6) 36.4 (36.2-36.7) 36.4 (36.1-36.7) 36.3 (36.1-36.6) 36.4 (36.2-36.7)
a
Data are given as number (percentage) of patients, unless otherwise indicated.

impact cost-effectiveness negatively.37 Alternatively, imple- reduce pollution risks. However, when evaluating cost-
menting better recycling programs for medical plastics could effectiveness, it is important to consider not only health care

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 Research Original Investigation Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery

Table 3. Rates of SSI

Patients with SSI, No. (%)

Wound Difference, percentage
Outcome Total protector Gauze points (95% CI) RRR, % (95% CI) P value P valuea
Intention-to-treat analysis
Patients, No. 458 229 229 NA NA NA NA
Any SSI 72 (15.7) 25 (10.9) 47 (20.5) 9.61 (3.00 to 16.22) 46.81 (16.64 to 66.06) .005 .005
Wound type
Clean-contaminated 50 (14.6) 18 (10.5) 32 (18.7) 8.19 (0.75 to 15.63) 43.75 (3.75 to 67.13) .03 NA
(n = 342)
Contaminated or dirty, 22 (19.0) 7 (12.1) 15 (25.9) 13.79 (−0.25 to 27.84) 53.33 (−5.96 to 79.45) .06 NA
infected (n = 116)
SSI type
Superficial 63 (13.8) 23 (10.0) 40 (17.5) 7.42 (1.15 to 13.70) 42.50 (7.16 to 64.39) .02 NA
Deep 7 (1.5) 3 (1.3) 4 (1.7) 0.44 (−1.81 to 2.68) 25.00 (−231.35 to 83.02) >.99 NA
Organ-space 4 (0.9) 0 4 (1.7) 1.75 (0.05 to 3.44) 100 (NA to 100) .12 NA
Per-protocol analysis
Patients, No. 412 210 202 NA NA NA NA
Any SSI 69 (16.7) 24 (11.4) 45 (22.3) 10.85 (3.68 to 18.02) 48.70 (19.04 to 67.49) .003 .003
Wound type
Clean-contaminated 47 (15.4) 17 (11.0) 30 (19.9) 8.90 (0.86 to 16.94) 44.80 (4.20 to 68.19) .03 NA
(n = 306)
Contaminated or dirty, 22 (20.8) 7 (12.7) 15 (29.4) 16.68 (1.39 to 31.98) 56.73 (2.51 to 80.79) .03 NA
infected (n = 106)
SSI type
Superficial 60 (14.6) 22 (10.5) 38 (18.8) 8.34 (1.54 to 15.13) 44.31 (9.26 to 65.82) .02 NA
Deep 7 (1.7) 3 (1.4) 4 (2.0) 0.55 (−1.95 to 3.06) 27.86 (−218.33 to 83.65) .72 NA
Organ-space 4 (1.0) 0 4 (2.0) 1.98 (0.06 to 3.90) 100 (NA to 100) .06 NA
a
Abbreviations: NA, not available; RRR, relative risk reduction; SSI, surgical site P value from the Cochran-Mantel-Haenszel test, stratified by type of wound
infection. (randomization stratification factor).

costs but also the device’s environmental impact and inter- open abdominal GI surgeries compared with traditional sur-
pret the findings cautiously. gical gauze. Despite the challenges of assessing the cost-
effectiveness and environmental impact of wound protec-
tors, the clinical benefits are evident. Innovative efforts should
concentrate on making these devices more environmentally
Conclusion sustainable while maintaining their effectiveness in infec-
This randomized clinical trial demonstrated that plastic wound tion prevention, prioritizing patient safety alongside ecologi-
protectors were effective in reducing the incidence of SSIs in cal responsibility.

ARTICLE INFORMATION Hospital, Hallym University College of Medicine, responsibility for the integrity of the data and the
Accepted for Publication: February 2, 2024. Chuncheon, Korea (B. M. Kang); Department of accuracy of the data analysis.
Surgery, Chung-Ang University Hospital, Chung-Ang Concept and design: Yoo, Lee, B.M. Kang,
Published Online: April 24, 2024. University College of Medicine, Seoul, Korea W.-K. Kang, Oh, H.J. Kim.
doi:10.1001/jamasurg.2024.0765 (B. K. Park); Department of Surgery, Chonnam Acquisition, analysis, or interpretation of data: Yoo,
Open Access: This is an open access article National University Hospital, College of Medicine, Mun, Kye, C.W. Kim, Y.Y. Park, B.M. Kang, B.K. Park,
distributed under the terms of the CC-BY License. Chonnam National University, Gwangju, Korea Kwak, W.-K. Kang, Bae, Hong.
© 2024 Yoo N et al. JAMA Surgery. (Kwak); Department of Surgery, Yeouido St Mary’s Drafting of the manuscript: Yoo, Mun, W.K. Kang,
Author Affiliations: Department of Surgery, Seoul Hospital, College of Medicine, The Catholic H.J. Kim.
St Mary’s Hospital, College of Medicine, The University of Korea, Seoul, Korea (W.-K. Kang); Critical review of the manuscript for important
Catholic University of Korea, Seoul, Korea (Yoo); Department of Surgery, Keimyung University and intellectual content: Yoo, Kye, C.W. Kim, Lee, Y.Y. Park,
Department of Surgery, St Vincent’s Hospital, Dongsan Medical Center, Daegu, Korea (Bae); B.M. Kang, B.K. Park, Kwak, Bae, Oh, Hong, H.J. Kim.
College of Medicine, The Catholic University of Department of Surgery, Seoul National University Statistical analysis: Yoo.
Korea, Suwon, Korea (Yoo, Mun, Kye); Department Bundang Hospital, Seongnam, Korea (Oh); Obtained funding: Yoo, Lee.
of Surgery, Ajou University Hospital, Suwon, Korea Department of Surgery, National Health Insurance Administrative, technical, or material support: Yoo,
(C. W. Kim); Department of Surgery, Uijeongbu St Service, Ilsan Hospital, Goyang, Korea (Hong); Mun, Key, C.W. Kim, Lee, Y.Y. Park, B.M. Kang,
Mary’s Hospital, College of Medicine, The Catholic Department of Surgery, EunPyeong St Mary’s B.K. Park, W.-K. Kang, Bae, H.J. Kim.
University of Korea, Uijeongbu, Korea (Lee); Hospital, College of Medicine, The Catholic Supervision: Kye, C.W. Kim, B.M. Kang, B.K. Park,
Department of Surgery, Kyung Hee University University of Korea, Seoul, Korea (H. J. Kim). Kwak, W.-K. Kang, Oh, Hong, H.J. Kim.
Hospital at Gangdong, Kyung Hee University Author Contributions: Drs H.J. Kim and Yoo had Conflict of Interest Disclosures: None reported.
College of Medicine, Seoul, Korea (Y. Y. Park); full access to all of the data in the study and take Funding/Support: This trial was supported by the
Department of Surgery, Chuncheon Sacred Heart Korean Surgical Infection Society, where the plastic

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 Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery Original Investigation Research

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