Modified Polyurethane Film Dressing For Skin Graft Donor Sites - Full Text View

Purpose

The purpose of this study is to determine whether the combination of perforated 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

U.S. FDA Resources

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 perforated 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:

Birdsell DC, Hein KS, Lindsay RL. The theoretically ideal donor site dressing. Ann Plast Surg. 1979 Jun;2(6):535-7.

James JH, Watson AC. The use of Opsite, a vapour permeable dressing, on skin graft donor sites. Br J Plast Surg. 1975 Apr;28(2):107-10.

Ramirez OM, Granick MS, Futrell JW. Optimal wound healing under Op-Site dressing. Plast Reconstr Surg. 1984 Mar;73(3):474-5.

Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg. 2004 Aug;53(2):132-6.

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

Keywords provided by Klinik Bogenhausen:

healing time

pain

infection

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Klinik Bogenhausen
Information provided by:	Klinik Bogenhausen
ClinicalTrials.gov Identifier:	NCT00600457