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

Primary Purpose

Colorectal Surgery, Wound Infections

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
wound protector
no wound protector
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Surgery focused on measuring colorectal surgery, wound infection, wound protector, laparoscopy, surgical site infection after laparoscopic colorectal surgery with minilaparotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elective laparoscopic colorectal resection with minilaparotomy

Exclusion Criteria:

  • emergency operation
  • patients under 18 years of age

Sites / Locations

  • Charité Campus Benjamin Franklin; Hindenburgdamm 30

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

no wound protector

wound protector

Arm Description

instead of wound protector, a woven drape is applied

after minilaparotomy, wound protector is applied

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
postoperative costs
the costs for the operation, for the hospital stay including re-admissions, and for the outpatient stay is analyzed
length of hospital stay
the total hospital stay including re-admissions is analyzed
cosmetic result
the satisfaction with the cosmeti result is analyzed in every patient by questionnaire 6 months postoperatively

Full Information

First Posted
January 14, 2010
Last Updated
July 6, 2011
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01049971
Brief Title
REDWIL: Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors
Acronym
REDWIL
Official Title
Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Surgery, Wound Infections
Keywords
colorectal surgery, wound infection, wound protector, laparoscopy, surgical site infection after laparoscopic colorectal surgery with minilaparotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no wound protector
Arm Type
Active Comparator
Arm Description
instead of wound protector, a woven drape is applied
Arm Title
wound protector
Arm Type
Experimental
Arm Description
after minilaparotomy, wound protector is applied
Intervention Type
Device
Intervention Name(s)
wound protector
Other Intervention Name(s)
Vi-Drape (Trademark) wound protector
Intervention Description
after minilaparotomy, the wound protector is applied
Intervention Type
Device
Intervention Name(s)
no wound protector
Intervention Description
use of woven drape instead of wound protector
Primary Outcome Measure Information:
Title
percentage of wound infections
Description
the total percentage of wound infections within 6 months postoperatively will be analyzed
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
colonialization of abdominal wall with bacteria
Description
a swab of the abdominal wall is taken before skin closure routinely in every participating patient and the bacteria found is analyzed
Time Frame
6 months postoperatively
Title
postoperative costs
Description
the costs for the operation, for the hospital stay including re-admissions, and for the outpatient stay is analyzed
Time Frame
6 months postoperatively
Title
length of hospital stay
Description
the total hospital stay including re-admissions is analyzed
Time Frame
6 months postoperatively
Title
cosmetic result
Description
the satisfaction with the cosmeti result is analyzed in every patient by questionnaire 6 months postoperatively
Time Frame
6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elective laparoscopic colorectal resection with minilaparotomy Exclusion Criteria: emergency operation patients under 18 years of age
Facility Information:
Facility Name
Charité Campus Benjamin Franklin; Hindenburgdamm 30
City
Berlin
ZIP/Postal Code
12200
Country
Germany

12. IPD Sharing Statement

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

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