REDWIL: Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors
Overview
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.
Full Title of Study: “Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: January 2011
Interventions
- Device: wound protector
- after minilaparotomy, the wound protector is applied
- Device: no wound protector
- use of woven drape instead of wound protector
Arms, Groups and Cohorts
- Active Comparator: no wound protector
- instead of wound protector, a woven drape is applied
- Experimental: wound protector
- after minilaparotomy, wound protector is applied
Clinical Trial Outcome Measures
Primary Measures
- percentage of wound infections
- Time Frame: 6 months postoperatively
- the total percentage of wound infections within 6 months postoperatively will be analyzed
Secondary Measures
- colonialization of abdominal wall with bacteria
- Time Frame: 6 months postoperatively
- a swab of the abdominal wall is taken before skin closure routinely in every participating patient and the bacteria found is analyzed
- postoperative costs
- Time Frame: 6 months postoperatively
- the costs for the operation, for the hospital stay including re-admissions, and for the outpatient stay is analyzed
- length of hospital stay
- Time Frame: 6 months postoperatively
- the total hospital stay including re-admissions is analyzed
- cosmetic result
- Time Frame: 6 months postoperatively
- the satisfaction with the cosmeti result is analyzed in every patient by questionnaire 6 months postoperatively
Participating in This Clinical Trial
Inclusion Criteria
- elective laparoscopic colorectal resection with minilaparotomy Exclusion Criteria:
- emergency operation – patients under 18 years of age
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Charite University, Berlin, Germany
- Provider of Information About this Clinical Study
- PD Dr. JP Ritz, Dr. JC Lauscher, Charité Campus Benjamin Franklin
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