Modified Polyurethane Film Dressing For Skin Graft Donor Sites

Wound Healing Clinical Trial

Official title:

Modified Polyurethane Film Dressing For Skin Graft Donor Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600457
• Other study ID #: MOPS-1
• Status: Completed
• Phase: N/A
• First received: January 23, 2008
• Last updated: December 15, 2008
• Start date: March 2007
• Est. completion date: September 2007

Study information

• Verified date: December 2008
• Source: Klinik Bogenhausen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults over age 18 who require skin grafting

Exclusion Criteria:

• Individuals under the age of 18.

Study Design

N/A

Related Conditions & MeSH terms

• Wound Healing

Intervention

Device:
• Polyurethane Film
The modified polyurethane film is combined with a secondary absorbent dressing and remained intact until the 10th postoperative day

Locations

Country	Name	City	State
Germany	Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Klinik Bogenhausen

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uncontrolled leakage		1-10th day postoperative	Yes
Secondary	pain		1-10th day postoperative	Yes
Secondary	infection		1-10th day postoperative	Yes
Secondary	epithelization status		10th day postoperative	Yes