Modified Polyurethane Film Dressing For Skin Graft Donor Sites

December 15, 2008 updated by: Klinik Bogenhausen
The purpose of this study is to determine whether the combination of modified polyurethane film and secondary absorbent dressing for skin graft donor sites avoids the regular uncontrolled leakage, but holds up the advantages of film dressings for this kind of wound.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

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
      • Munich, Germany
        • Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich

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:

  • Adults over age 18 who require skin grafting

Exclusion Criteria:

  • Individuals under the age of 18.

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?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A,1
Device: Polyurethane Film
The modified polyurethane film is combined with a secondary absorbent dressing and remained intact until the 10th postoperative day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
uncontrolled leakage
Time Frame: 1-10th day postoperative
1-10th day postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
pain
Time Frame: 1-10th day postoperative
1-10th day postoperative
infection
Time Frame: 1-10th day postoperative
1-10th day postoperative
epithelization status
Time Frame: 10th day postoperative
10th day postoperative

Collaborators and Investigators

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

Sponsor

Klinik Bogenhausen

Investigators

  • Principal Investigator: Ulf Dornseifer, MD, Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich-Bogenhausen, Technical University Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Estimate)

December 16, 2008

Last Update Submitted That Met QC Criteria

December 15, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MOPS-1

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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