Modified Polyurethane Film Dressing For Skin Graft Donor Sites

This study has been completed.
Sponsor:
Information provided by:
Klinik Bogenhausen
ClinicalTrials.gov Identifier:
NCT00600457
First received: January 23, 2008
Last updated: December 15, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention
Wound Healing
Device: Polyurethane Film

Study Type: Observational
Official Title: Modified Polyurethane Film Dressing For Skin Graft Donor Sites

Further study details as provided by Klinik Bogenhausen:

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

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 ]

Enrollment: 30
Study Start Date: March 2007
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A,1 Device: Polyurethane Film
The modified polyurethane film is combined with a secondary absorbent dressing and remained intact until the 10th postoperative day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults over age 18 who require skin grafting

Exclusion Criteria:

  • Individuals under the age of 18.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600457

Locations
Germany
Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich
Munich, Germany
Sponsors and Collaborators
Klinik Bogenhausen
Investigators
Principal Investigator: Ulf Dornseifer, MD Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich-Bogenhausen, Technical University Munich
  More Information

Publications:
Responsible Party: Ulf Dornseifer, MD, Department of Plastic Surgery, Academic Hospital Munich-Bogenhausen, Technical University Munich
ClinicalTrials.gov Identifier: NCT00600457     History of Changes
Other Study ID Numbers: MOPS-1
Study First Received: January 23, 2008
Last Updated: December 15, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinik Bogenhausen:
healing time
pain
infection

ClinicalTrials.gov processed this record on April 15, 2014