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

July 6, 2011 updated by: Charite University, Berlin, Germany

Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Charité Campus Benjamin Franklin; Hindenburgdamm 30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective laparoscopic colorectal resection with minilaparotomy

Exclusion Criteria:

  • emergency operation
  • patients under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of wound infections
Time Frame: 6 months postoperatively
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
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
6 months postoperatively
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
6 months postoperatively
length of hospital stay
Time Frame: 6 months postoperatively
the total hospital stay including re-admissions is analyzed
6 months postoperatively
cosmetic result
Time Frame: 6 months postoperatively
the satisfaction with the cosmeti result is analyzed in every patient by questionnaire 6 months postoperatively
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 15, 2010

Study Record Updates

Last Update Posted (Estimate)

July 7, 2011

Last Update Submitted That Met QC Criteria

July 6, 2011

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4/089/07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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