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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT01049971

Collaborator

(none)

109

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Surgery Wound Infections	Device: wound protector Device: no wound protector	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: no wound protector instead of wound protector, a woven drape is applied	Device: no wound protector use of woven drape instead of wound protector
Experimental: wound protector after minilaparotomy, wound protector is applied	Device: wound protector after minilaparotomy, the wound protector is applied Other Names: Vi-Drape (Trademark) wound protector

Arm

Intervention/Treatment

Active Comparator: no wound protector

instead of wound protector, a woven drape is applied

Device: no wound protector

use of woven drape instead of wound protector

Experimental: wound protector

after minilaparotomy, wound protector is applied

Device: wound protector

after minilaparotomy, the wound protector is applied

Other Names:

Vi-Drape (Trademark) wound protector

Outcome Measures

Primary Outcome Measures

percentage of wound infections [6 months postoperatively]
the total percentage of wound infections within 6 months postoperatively will be analyzed

Secondary Outcome Measures

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