A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination and Surgical Site Infection in Colorectal Surgery
Phase: NA
Conditions: Colorectal Surgery
Sponsor: Scott Steele

 
 
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A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection 
Reduces Incisional Contamination and Surgical Site Infection in Colorectal Surgery 
 
 
 
Protocol Date:   
February 26, 2020 
 
Principal Investigator: 
    Scott Steele, M.D. 
Digestive Disease and Surgery Institute 
9500 Euclid Avenue A30 
Cleveland, Ohio 44195 
Tel: 216 444-4715 
 
Email: steeles3@ccf.org 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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TABLE OF CONTENTS 
 
1. BACKGROUND  
 
2. STUDY OBJECTIVE 
 
3. SELECTION OF PATIENTS 
3.1. Inclusion Criteria 
3.2. Exclusion Criteria 
3.3. Statistical Considerations 
 
4. STUDY DESIGN 
4.1. Consent 
4.2. Study Process 
4.3. Blinded Assessment 
4.4. Data Recording 
4.5. Definitions 
 
5. ADVERSE EVENTS AND POTENTIAL RISKS  
5.1. Definition 
5.2. Reporting Adverse Events 
 
6. REFERENCES  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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1. BACKGROUND 
Surgical site infection (SSI) remains a persistent and morbid problem in colorectal surgery with 
published rates ranging from 7 to 25% 1-6. The negative outcomes of SSI are well reported and 
include a significant increase in morbidity, length of hospital stay, readmissions and healthcare-
associated cost7, 8.  Therefore, strategies to reduce the incidence of SSI following colorectal surgery 
are important to improve overall patient outcomes, reduce healthcare-associated costs and provide 
value-based healthcare to surgical patients. 
Since 2005, our institution has been an active participant of the American College of Surgeons 
(ACS) National Surgical Quality Improvement Program (NSQIP), and our SSI rates have been 
compared with other NSQIP centers; in 2006, we were found to be a high-outlier institution for SSI  
9.  The ACS-NSQIP greatly facilitated our understanding of the reasons behind our high SSI rates, 
the patient profiles that are associated with SSIs, and how we can make improvements. This 
previously published work helped us to develop a Surgical Site Infection Prevention Bundle to 
reduce SSI rates after colorectal surgical procedures performed at the Cleveland Clinic. This bundle 
was introduced in February 2014. Between 2013 and 2015, 2250 abdominal colorectal surgical 
procedures were performed, including 986 (43.8%) during the prebundle period and 1264 (56.2%) 
after the bundle project. Patient characteristics and comorbidities were similar in both periods. The 
overall surgical site infection rate decreased from 11.8% prebundle to 6.6% at the bundle period 
(P < 0.001). Although a decrease for all types of surgical site infections was observed after the 
implementation, a significant reduction was achieved in the organ-space subgroup (5.5%–1.7%; P < 
0.001).  Since then, the elements of this bundle became the standard of care in all elective colorectal 
surgeries done at the Cleveland Clinic. The most important elements of the bundle include 
mechanical bowel preparation, antimicrobial antiseptic skin cleanser, prophylactic antibiotic 
(ceftriaxone + Flagyl) 1 hour prior to incision, wound irrigation with normal saline, and the usage 
of wound protector.  The outcomes of this SSI prevention bundle was recently published10. 
Although this study was not designed to pinpoint the relative weight of each of these elements in 
reducing SSIs, participating colorectal surgeons at our institute accredit a big role for wound 
protectors and irrigation along with prophylactic antibiotics.  
Key to the pathogenesis of SSI is the degree of intraoperative bacterial contamination of the surgical 
wound. Preventing contamination of the wound or reducing the bacterial load through the use of 
barrier wound protectors or intraoperative wound irrigation has shown significant promise 
individually and is an ongoing strategic focus to reduce wound infections after surgery 11-13.  A 
similar role can be attributed to prophylactic antibiotics administered within one hour prior fist 
incision.     
The importance of wound protectors and intraoperative wound irrigation can be elucidated by 
examining published meta-analyses. The first represented 6 randomized clinical trials (RCTs) and 
1008 patients evaluated for the effect of wound protectors in reducing the risk of surgical site 
infection (SSI) after gastrointestinal surgery. A significant decrease in SSI rates (RR = 0.55, 95% 
confidence Interval (CI) 0.31-0.98, P = 0.04) was noted13. A more recent meta-analysis included 
eighteen randomized controlled trials with 3808 patients. The use of wound protectors was 
associated with the reduced incidence of overall SSI (OR 0.59; 95% CI 0.43-0.81; z = 3.30; 

 
 
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p < 0.001) and superficial SSI (OR 0.42; 95% CI 0.18-0.95; z = 2.09; p < 0.04). In addition, wound 
protectors successfully reduced the risk of SSI in clean-contaminated wounds (OR 0.67; 95% CI 
0.46-0.98; z = 2.06; p < 0.04) as well as in contaminated wounds (OR 0.24; 95% CI 0.12-0.49; 
z = 3.96; p < 0.0001)11. Based on that, the WHO global guidelines for the prevention of surgical site 
infection recommends the usage of wound protector devices in clean-contaminated, contaminated 
and dirty abdominal surgical procedures for the purpose of reducing the rate of SSI14.  
The usage of intraoperative wound irrigation has also been shown to significantly reduce the risk of 
SSI via multiple RTC. A significant reduction in SSI rates after intraoperative wound irrigation with 
any solution was noted compared to no irrigation (OR = 0.54, 95 % CI 0.42; 0.69, p < 0.0001) 13.  
A surgical device that combines continuous wound irrigation and barrier protection will have an 
important SSI prevention advantage. CleanCision is a recently developed apparatus that serves this 
dual purpose and was found to reduce bacterial wound contamination in preclinical and clinical 
trials. A prospective multicenter pilot study was conducted by colorectal surgeons at 7 large tertiary-
care referral centers in the USA15. The study was designed to evaluate the bacteriology of the wound 
incision edge when an investigational device (CleanCision wound protector) that combines 
continuous wound irrigation and barrier protection was used during colorectal surgery. A total of 
97 patients (11 roll-in and 86 treatments) were enrolled in the study. All patients completed the 30-
day follow-up. The 86 treatment patients were used for the primary analysis. Use of the study device 
was associated with a 71% reduction in enteric bacterial contamination (9.5% vs 33.3%, P < 0.001), 
and 66% reduction in overall bacterial contamination (11.9 vs. 34.5%, P < 0.001) at the protected 
incision edge versus the exposed incision edge. In addition, analysis of the skin organisms on the 
incision edge prior to device placement compared to the protected incision edge at the time of device 
removal demonstrated an 86% reduction after use of the study device (16.7 vs. 2.4%, P < 0.001). 
There were no deaths and no device-related adverse events reported in the study. There were 4 
wound-related adverse events, other than SSI, reported: 1 skin necrosis, 1 non-infections erythema, 
1 hematoma and 1 wound opening up postoperatively. All 4 events were not device related as 
determined by the site investigator.  Although SSI was not the endpoint that this study was designed 
to examine, the observed overall SSI rate was 1.2%, such rate is lower than reported at our institute 
for colorectal surgery (6.6%)15.  
As part of our continuous effort to reduce SSI, additional measures such as CleanCision wound 
protector could bring our SSI rates even further. This will translate in better patient care and reduced 
health care cost.  
Supported by the previously published multicenter clinical trial 11, 13, 15, this study aims to investigate 
the effect of using CleanCision wound protector on the rates of postoperative Surgical Site 
Infections in comparison to the current wound protector (Alexis O) being used at our institute.   
 
 
 
 
 
 

 
 
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2. STUDY OBJECTIVE  
 
To evaluate the 30 day post-operative SSI rate in patients undergoing elective colorectal 
surgical procedures after intraoperative usage of Alexis O wound protector vs. CleanCision 
continuous irrigation wound protector.    
 
3. SELECTION OF PATIENTS 
 
3.1 Inclusion Criteria 
  
 Patients 18 years old and above.  
 Elective colorectal surgery with a planned resection including open or laparoscopic 
surgeries.   
 Patients with a clean –contaminated, contaminated, or dirty wound classification 
 Patients undergoing Standard of care SSI reduction bundle including Prophylactic 
AB and mechanical bowel preparation.   
 Anticipated incision length of 3-17 cm 
 
3.2 Exclusion Criteria 
 
 Patients with a preexisting stoma.  
 Patients with prior laparotomy within 15 days. 
 Patients with an active infection or systemic antibiotic therapy within 1 week prior 
to surgery with the exception of preoperative antimicrobial prophylaxis. 
 Emergent/ urgent surgery. 
 
3.3 Statistical Considerations 
 
Planned Data Analysis 
Descriptive statistics will be computed for all variables including mean ± standard deviation 
or median [25th, 75th percentiles] for continuous factors and frequency (percent) for 
categorical variables. Univariate analyses will be conducted to compare the distribution of 
pre-op characteristics across study groups using ANOVA for continuous variables and Chi-
square or Fisher's exact test for categorical variables. 
 
For purposes of statistical analysis, a subset analysis may be done based on laparoscopic vs. 
open procedures, patients with high risk for SSI, type of surgery, or other clinically 
significant co-factors.  All data will be analyzed with the use of SAS (version 9.4, The SAS 
Institute, Cary, NC), SPSS statistical software (SPSS Inc., Chicago, IL),  or R version 3.1.2 
(www.R-project.org).  A p-value <0.05 will considered statistically significant. 
 
Sample Size Calculations   
The sample size calculation using estimates of SSIs from the Papaconstantinou et al. 
Multicenter trial. This study showed an incisional SSI rate of 1.2% in those that completed 
the protocol. In comparison, the incisional SSI rate using the current standard of care 

 
 
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practice at our institute is 4.8 %.  On the other hand, the overall SSI rates in Papaconstantinou 
et al. multicenter trial is 3.7% and in the current standard of practice at the Cleveland Clinic, 
the overall SSI rate is 6.6%.  We used these two estimates of SSI rates to calculate the sample 
size.  Using the incisional SSI, we assumed a 3.6% drop rate if the study hypothesis is true. 
We are assuming equal-sized treatment groups and alpha = 0.05.  Based on this assumption, 
a total of 277 subjects in each study group will be needed to achieve 70% power, 351 
subjects in each study group will be needed to achieve 80% power, and 470 subjects will be 
needed to achieve 90% power. On the other hand, using the overall SSI rates and assuming 
a drop of 2.9% , a total of 716  subjects in each study group will be needed to achieve 70% 
power, 805 subjects in each study group will be needed to achieve 80% power, and  1219 
subjects will be needed to achieve 90% power.  
 
Based on the above, 351 patients will be enrolled in the study in each arm with a total of 702 
patients.  
 
Reporting of Results 
Aggregate and anonymous, in text and table format, for publication in a medical journal. 
 
4. STUDY DESIGN 
This industry-initiated trial will be a prospective randomized controlled trial. The study will include 
patients undergoing elective colorectal surgical procedures. All patients will receive the standard of 
care SSI prevention bundle. Part of this bundle is the utilization of wound protectors. The current 
system used at Cleveland Clinic is Alexis wound protectors/retractors (Applied Medical, Avenida 
Empresa Rancho Santa Margarita, CA). It provides 360° of circumferential, atraumatic dry 
retraction. Independent wound irrigation is also utilized. CleanCision is a novel FDA approved 
irrigating wound protector/ retractor that combines mechanical wound protection with an active 
continuous irrigation via microfluidic system that circulates the irrigation throughout the whole 
thickness of the protecting membrane. The safety and possible advantage of this new system has 
been shown through preclinical and clinical studies. Prescient Surgical, based in San Carlos, 
California, has an FDA marketing clearance for its CleanCision Wound Retraction and Protection 
System.  
4.1 Consent 
 
Patients will be identified prospectively by the treating surgeon according to the inclusion / 
exclusion criteria. Patients will be offered to participate in the study in the preoperative setting. The 
patient eligibility to participate in the study will be verified by the study team. The study details will 
be explained to the patient by a member of the study team. The consent conversation will take place 
in a private room and a sufficient time interval will be offered to allow the patient to comprehend 
the study details. Enrolled patients will be randomly assigned via REDCap in a 1:1 ratio to either 
the control arm (Alexis wound protector) or the intervention arm (CleanCision Wound retractor 
system). The randomization will be done by a delegated member of the study team. Consent will be 
documented in the medical record. 
 
 

 
 
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4.2 Study Process 
 
Utilization of CleanCision wound protector/ Irrigation system is free of charge without extra 
financial charges to the enrolled patients.  
The study team will confirm that patients are adhering to pre- intra- and post-operative standard of 
care SSI prevention bundle. The Bundle main elements are: 
 
Patient bathing with Hibiclens preoperatively. 
 
The patient use CHG (SAGE) wipes. 
 
Mechanical bowel preparation.  
 
Antibiotics Prophylaxis (ceftriaxone + Flagyl) given approximately 1 hour prior to 
incision. If the patient is allergic to above antibiotics, aztreonam or imipenem are used as 
prophylactic antibiotics.  
 
The usage of wound protector and the placement and removal of blue towels under the 
Alexis wound protectors for control cases. 
 
Use chlorhexidine gluconate and isopropyl alcohol for preoperative skin preparation 
 
Wound irrigated with 100cc of fresh saline.  
 
Separate instrument tray used for closing the incision. 
 
Gloves changed before closing the incision.  
 
Suction tip changed before closing the incision.  
 
Dressing left intact for 48 hours postop. 
The usage of a wound protector along with wound irrigation intra-operatively is considered standard 
of care. This study entails utilizing two type of wound protectors, both are considered standard of 
care in terms of providing the baseline needed protection.  Intra-operatively, either CleanCision 
Wound protector/ irrigation system or Alexis O wound protector will be chosen. Additional wound 
irrigation and washing with Normal Saline will be performed before skin closure as part of the 
standard of care. This will include both study groups (patients with Alexis O wound protectors and 
CleanCision wound protectors). In the CleanCision group, a broad spectrum antibiotic may be added 
to the irrigation fluid. Post-operatively, patients will be followed for wound infections according to 
the standard of care in the department of colorectal surgery. For patients undergoing colorectal 
procedures at the department of colorectal surgery, the timing of outpatient post-operative follow-
up can be variable depending on the type of procedure performed, the treating surgeon, the patient 
place of residence, and the patient general medical condition.  To avoid variability, patients will be 
asked to send a photographic documentation of the wound at day 7 ± 7 days and day 30 ± 7 days 
postoperatively to the study team. The photographs will be stored in the secure REDCap database. 
If a patient presents for follow-up at the outpatient clinic at the above time points and as part of 
standard of care, a photograph of the wound can be obtained during the outpatient visit by the study 
team member.  The purpose of these photographs as well as the time points will be explained to the 
patient at the time study enrollment. Patients refusing or incapable of sending the photographs will 
not be enrolled in the study.  For study enrolled patients’ a reminder will be added to the hospital 
discharge note asking the patient to send the photographs to the above email address at the 
corresponding time points.  

 
 
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4.3 Blinded Assessment 
The study team member will evaluate the images for signs of surgical site infection and will be 
blinded to the type of wound protector used intraoperatively. This will be done at regular intervals 
and in aggregate. 
4.4 Data Recording 
 
Data will be collected from EPIC by the study team. A secure REDCap database will be utilized to 
store the data. The following variables will be recorded: 
 
A) Preoperative variables: 
 Patient Demographics: 
o DOB, age at the time of surgery, gender, race, Height, weight and body mass index 
(BMI) at the time of surgery.  
 American Society of Anesthesiologists physical status classification (ASA score). 
 Preoperative diagnosis and patient’s History of present illness.   
 Adherence to SSI prevention bundle (elements defined above). 
 Risk factors for SSI including nutritional status (represented by patient current weight) and 
immune status including WBC and differentials, history of smoking, and any other risk 
factors for SSI.  
 
B) Intraoperative variables: 
 Operating surgeon. 
 Length of incision/wound. 
 Surgical approach (open vs. laparoscopic vs transanal). 
 Device deficiencies including (leaking of fluid, breakage of plastic sheath, ring malfunction 
in CleanCision wound protector). 
 
C) Postoperative variables: 
 In-patient Progress notes.  
 The development of SSI per the criteria defined above along with any related investigation 
/ clinical encounter needed for such diagnosis. The timing of SSI development.  
 
4.5 Definitions 
 
The World Health Organization (WHO) definitions of wound classifications and SSIs were adopted 
in this study. The WHO definitions are based on the Center for Disease Control and Prevention 
(CDC) National Healthcare Safety Network (NHSN). NHSN is the nation’s most widely used 
healthcare-associated infection tracking system 14.  
 
 

 
 
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Surgical wound classification 
1. Clean: An uninfected operative wound in which no inflammation is encountered and the 
respiratory, alimentary, genital, or uninfected urinary tracts are not entered. In addition, clean 
wounds are primarily closed and, if necessary, drained with closed drainage.  
2. Clean-contaminated: Operative wounds in which the respiratory, alimentary, genital, or urinary 
tracts are entered under controlled conditions and without unusual 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.  
3. Contaminated: Open, fresh, accidental wounds. In addition, operations with major breaks in 
sterile technique (for example, open cardiac massage) or gross spillage from the gastrointestinal 
tract, and incisions in which acute, non-purulent inflammation is encountered including necrotic 
tissue without evidence of purulent drainage (for example, dry gangrene) are included in this 
category.  
4. Dirty or infected: Includes old traumatic wounds with retained devitalized tissue and those that 
involve existing clinical infection or perforated viscera. This definition suggests that the organisms 
causing post-operative infection were present in the operative field before the operation. 
Surgical Site Infections (SSI) 
Superficial SSI 
A) An infection occurring within 30 days of the operative procedure (where day 1 = the procedure 
date).  
 
B) AND involves only skin and subcutaneous tissue of the incision.  
 
C) AND patient has at least one of the following:  
 Purulent drainage from the superficial incision.  
 Organisms identified from an aseptically-obtained specimen from the superficial incision or 
subcutaneous tissue by a culture or non-culture based microbiologic testing method which 
is performed for purposes of clinical diagnosis or treatment.  
 Superficial incision that is deliberately opened by a surgeon or other designee and culture or 
non-culture based testing is not performed AND patient has at least one of the following 
signs or symptoms: pain or tenderness; localized swelling; erythema; or heat.  
 Diagnosis of a superficial incisional SSI by the surgeon or other designee. 
 
The following do not qualify as superficial SSI: 
 Diagnosis/treatment of cellulitis (redness/warmth/swelling), by itself, does not meet 
criterion “d” for superficial incisional SSI. Conversely, an incision that is draining or that 
has organisms identified by culture or non-culture based testing is not considered a cellulitis.  
 A stitch abscess alone (minimal inflammation and discharge confined to the points of suture 
penetration).  

 
 
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 A localized stab wound or pin site infection- Such an infection might be considered either a 
skin or soft tissue infection, depending on its depth, but not an SSI. 
 
Deep SSI 
A) An infection occurring within 30 days of the operative procedure (where day 1 = the procedure 
date).  
 
B) AND involves deep soft tissues of the incision (for example, fascia and muscle layers)  
 
C) AND patient has at least one of the following:  
 Purulent drainage from the deep incision.  
 Deep incision that spontaneously dehisces, or is deliberately opened or aspirated by a 
surgeon or other designee AND organism is identified by a culture or non-culture based 
microbiologic testing method which is performed for purposes of clinical diagnosis or 
treatment or culture or non-culture based microbiologic testing method is not performed 
AND patient has at least one of the following signs or symptoms: fever (>38°C); localized 
pain or tenderness. A culture or non-culture based test that has a negative finding does not 
meet this criterion.  
 An abscess or other evidence of infection involving the deep incision that is detected on 
gross anatomical or histopathologic exam, or imaging test. 
 
 
Organ/Space SSI 
A) An infection occurring within 30 days of the operative procedure (where day 1 = the procedure 
date).  
 
B) AND infection involves any part of the body deeper than the fascia/muscle layers that is opened 
or manipulated during the operative procedure.  
 
C) AND patient has at least one of the following: 
 Purulent drainage from a drain that is placed into the organ/space (for example, closed 
suction drainage system, open drain, T-tube drain, CT guided drainage) 
 Organisms are identified from fluid or tissue in the organ/space by a culture or non-culture 
based microbiologic testing method which is performed for purposes of clinical diagnosis 
or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST). 
 An abscess or other evidence of infection involving the organ/space that is detected on gross 
anatomical or histopathologic exam, or imaging test evidence suggestive of infection. 
 
D) AND at least one criterion for a specific organ/space infection site listed below 
-Gastrointestinal tract infections, excluding, gastroenteritis and appendicitis, must meet at 
least one of the following criteria: 
1. Patient has one of the following: 
a. An abscess or other evidence of gastrointestinal tract infection on gross 
anatomic or histopathologic exam. 
b. An abscess or other evidence of gastrointestinal tract infection on gross 

 
 
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anatomic or histopathologic exam. 
AND organism(s) identified from blood by a culture or non-culture based 
microbiologic testing method, which is performed for purposes of clinical diagnosis or 
treatment.  
 
Intraabdominal Infection 
1. Patient has organism(s) identified from an abscess or from purulent material from 
intraabdominal space by a culture or non-culture based microbiologic testing method 
which is performed for purposes of clinical diagnosis or treatment. 
2. Patient has at least one of the following: 
a. An abscess or other evidence of intraabdominal infection on gross anatomic or 
histopathologic exam. 
b. An abscess or other evidence of intraabdominal infection on gross anatomic or 
histopathologic exam. 
AND organism(s) identified from blood by a culture or non-culture based microbiologic 
testing method, which is performed for purposes of clinical diagnosis or treatment. 
 
3. Patient has at least two of the following: fever (>38.0°C), hypotension, nausea, vomiting, 
abdominal pain or tenderness. 
 And at least one of the following: 
a. organism(s) seen on Gram stain and/or identified from intraabdominal fluid or tissue 
obtained during invasive procedure or from an aseptically-placed drain in the 
intraabdominal space (for example, closed suction drainage system, open drain, T-
tube drain, CT guided drainage) by a culture or non-culture based microbiologic 
testing method which is performed for purposes of clinical diagnosis or treatment. 
b. Organism(s) identified from blood by a culture or non-culture based microbiologic 
testing method which is performed for purposes of clinical diagnosis or treatment. 
c. AND imaging test evidence suggestive of infection (for example, ultrasound, CT 
scan, MRI, ERCP, radiolabel scans [gallium, technetium, etc.] or on abdominal x-
ray), which if equivocal is supported by clinical correlation, specifically, physician 
documentation of antimicrobial treatment for intraabdominal infection. 
  
 
5. ADVERSE EVENTS 
 
5.1 Definition 
An adverse event (AE) is any unfavorable or unintended event, physical or psychological, 
associated with a research study, which causes harm or injury to a research participant as a 
result of the participant’s involvement in a research study. The event can include abnormal 
laboratory findings, symptoms, or disease associated with the research study. The event does 
not necessarily have to have a causal relationship with the research, any risk associated with 
the research, the research intervention, or the research assessments.  
 

 
 
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Adverse events may be the result of the interventions and interactions used in the research; 
the collection of identifiable private information in the research; an underlying disease, 
disorder, or condition of the subject; and/or other circumstances unrelated to the research or 
any underlying disease, disorder, or condition of the subject.  
 
 
5.2 Reporting Adverse Events 
 
Although we do not anticipate any serious adverse events, all reportable serious adverse 
events will adhere to the policy guidelines of the IRB and the sponsor, if applicable. All 
other adverse events associated with surgery in the 30 day post-operative setting will be 
recorded on an adverse event log and submitted to the Cleveland Clinic IRB on an annual 
basis. 
 
 
6. REFERENCES 
 
 
1. 
Walz JM, Paterson CA, Seligowski JM, et al. Surgical site infection following bowel 
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Smith RL, Bohl JK, McElearney ST, et al. Wound Infection after Elective Colorectal 
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3. 
Konishi T, Watanabe T, Kishimoto J, et al. Elective colon and rectal surgery differ in risk 
factors for wound infection: Results of prospective surveillance. Annals of surgery. 
2006;244:758-763. 
4. 
de Oliveira AC, Ciosak SI, Ferraz EM, et al. Surgical site infection in patients submitted to 
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Fujii S, Tsukamoto M, Fukushima Y. Systematic review of laparoscopic vs open surgery for 
colorectal cancer in elderly patients. World J Gastrointest Oncol. 2016;8:573-582. 
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Serra-Aracil X, García-Domingo MI, Parés D, et al. Surgical site infection in elective 
operations for colorectal cancer after the application of preventive measures. Archives of 
Surgery. 2011;146:606-612. 
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de Lissovoy G, Fraeman K, Hutchins V, et al. Surgical site infection: Incidence and impact 
on hospital utilization and treatment costs. American Journal of Infection Control. 
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Tanner J, Khan D, Aplin C, et al. Post-discharge surveillance to identify colorectal surgical 
site infection rates and related costs. Journal of Hospital Infection. 2009;72:243-250. 
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Wick EC, Vogel JD, Church JM, et al. Surgical site infections in a "High Outlier" institution: 
Are colorectal surgeons to blame? Diseases of the colon and rectum. 2009;52:374-379. 
10. 
Gorgun E, Rencuzogullari A, Ozben V, et al. An Effective Bundled Approach Reduces 
Surgical Site Infections in a High-Outlier Colorectal Unit. Diseases of the colon and rectum. 
2018;61:89-98. 

 
 
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11. 
Sajid MS, Rathore MA, Sains P, et al. A systematic review of clinical effectiveness of wound 
edge protector devices in reducing surgical site infections in patients undergoing abdominal 
surgery. Updates in Surgery. 2017;69:21-28. 
12. 
Ruiz-Tovar J, Santos J, Arroyo A, et al. Effect of peritoneal lavage with clindamycin-
gentamicin solution on infections after elective colorectal cancer surgery. Journal of the 
American College of Surgeons. 2012;214:202-207. 
13. 
Mueller TC, Loos M, Haller B, et al. Intra-operative wound irrigation to reduce surgical site 
infections after abdominal surgery: a systematic review and meta-analysis. Langenbeck's 
archives of surgery. 2015;400:167-181. 
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Solomkin J, Gastmeier P, Bischoff P, et al. WHO Guidelines to prevent surgical site 
infections-Authors' reply. Lancet Infect Dis. 2017;17:262-264. 
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Papaconstantinou HT, Ricciardi R, Margolin DA, et al. A Novel Wound Retractor 
Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination 
in Colorectal Surgery. World journal of surgery. 2018;42:3000-3007. 

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