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

NCT ID: NCT01049971

Last Updated: 2011-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-01-31

Brief Summary

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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

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Conditions

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Colorectal Surgery Wound Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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no wound protector

instead of wound protector, a woven drape is applied

Group Type ACTIVE_COMPARATOR

no wound protector

Intervention Type DEVICE

use of woven drape instead of wound protector

wound protector

after minilaparotomy, wound protector is applied

Group Type EXPERIMENTAL

wound protector

Intervention Type DEVICE

after minilaparotomy, the wound protector is applied

Interventions

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wound protector

after minilaparotomy, the wound protector is applied

Intervention Type DEVICE

no wound protector

use of woven drape instead of wound protector

Intervention Type DEVICE

Other Intervention Names

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Vi-Drape (Trademark) wound protector

Eligibility Criteria

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Inclusion Criteria

* elective laparoscopic colorectal resection with minilaparotomy

Exclusion Criteria

* emergency operation
* patients under 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charité Campus Benjamin Franklin

Locations

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Charité Campus Benjamin Franklin; Hindenburgdamm 30

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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EA4/089/07

Identifier Type: -

Identifier Source: org_study_id

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