Modified Polyurethane Film Dressing For Skin Graft Donor Sites - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 23, 2008

Last Updated Date

December 15, 2008

Start Date ^†

March 2007

Current Primary Outcome Measures ^†

uncontrolled leakage [ Time Frame: 1-10th day postoperative ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00600457 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

pain [ Time Frame: 1-10th day postoperative ] [ Designated as safety issue: Yes ]
infection [ Time Frame: 1-10th day postoperative ] [ Designated as safety issue: Yes ]
epithelization status [ Time Frame: 10th day postoperative ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Modified Polyurethane Film Dressing For Skin Graft Donor Sites

Official Title ^†

Modified Polyurethane Film Dressing For Skin Graft Donor Sites

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Condition ^†

Wound Healing

Intervention ^†

Device: Polyurethane Film

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

September 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Adults over age 18 who require skin grafting

Exclusion Criteria:

Individuals under the age of 18.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00600457

Responsible Party

Ulf Dornseifer, MD, Department of Plastic Surgery, Academic Hospital Munich-Bogenhausen, Technical University Munich

Secondary IDs ^††

Study Sponsor ^†

Klinik Bogenhausen

Collaborators ^††

Investigators ^†

Principal Investigator:

Ulf Dornseifer, MD

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

Information Provided By

Klinik Bogenhausen

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.