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

Not Applicable

Completed

• Conditions: Colorectal Surgery; Wound Infections
• Interventions: Device: no wound protector; Device: wound protector

• Registration Number: NCT01049971
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-12
• Study Start: 2007-12
• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-15
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-07-06
• Last Update Posted: 2011-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• elective laparoscopic colorectal resection with minilaparotomy

Exclusion Criteria

• emergency operation
• patients under 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no wound protector	no wound protector	instead of wound protector, a woven drape is applied
wound protector	wound protector	after minilaparotomy, wound protector is applied

Primary Outcome Measures

Name	Time	Method
percentage of wound infections	6 months postoperatively	the total percentage of wound infections within 6 months postoperatively will be analyzed

Secondary Outcome Measures

Name	Time	Method
colonialization of abdominal wall with bacteria	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	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	6 months postoperatively	the total hospital stay including re-admissions is analyzed
cosmetic result	6 months postoperatively	the satisfaction with the cosmeti result is analyzed in every patient by questionnaire 6 months postoperatively

Trial Locations

Locations (1)

Charité Campus Benjamin Franklin; Hindenburgdamm 30; 🇩🇪 Berlin, Germany