REDWIL: Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors

Study Overview
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Brief Summary
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Surgical site infection is common in colorectal surgery leading to increased postoperative pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence, reducing the wound infection rate is a major aim in abdominal surgery. Wound protectors were invented for retracting the abdominal wall and keeping the abdominal wall sterile in order to reduce bacterial colonialization of the wound and wound infections. This is a prospective-randomized trial comparing use of wound protectors versus woven drapes in laparoscopic colon resections with minilaparotomy.

Official Title
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Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors

Conditions
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Colorectal Surgery, Wound Infections

Intervention / Treatment
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* Device: wound protector
* Device: no wound protector


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective laparoscopic colorectal resection with minilaparotomy Exclusion Criteria: emergency operation patients under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: no wound protector<br>instead of wound protector, a woven drape is applied | Device: no wound protector<br>* use of woven drape instead of wound protector<br>|
| Experimental: wound protector<br>after minilaparotomy, wound protector is applied | Device: wound protector<br>* after minilaparotomy, the wound protector is applied<br>* Other names: Vi-Drape (Trademark) wound protector;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of wound infections | the total percentage of wound infections within 6 months postoperatively will be analyzed | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colonialization of abdominal wall with bacteria | a swab of the abdominal wall is taken before skin closure routinely in every participating patient and the bacteria found is analyzed | 6 months postoperatively | 
| postoperative costs | the costs for the operation, for the hospital stay including re-admissions, and for the outpatient stay is analyzed | 6 months postoperatively | 
| length of hospital stay | the total hospital stay including re-admissions is analyzed | 6 months postoperatively | 
| cosmetic result | the satisfaction with the cosmeti result is analyzed in every patient by questionnaire 6 months postoperatively | 6 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal surgery, wound infection, wound protector, laparoscopy, surgical site infection after laparoscopic colorectal surgery with minilaparotomy