Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel

Not Applicable

Completed

• Conditions: Reepithelialization of Skin Graft Donor Sites
• Interventions: Device: modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK); Device: Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing

• Registration Number: NCT01055925
• Lead Sponsor: Klinik Bogenhausen

Brief Summary

The almost single disadvantage of conventional polyurethane film dressings, an uncontrolled leakage, is probably as often described as its numerous advantages for split-thickness skin graft (STSG) donor sites. This shortcoming can be overcome by perforating the polyurethane dressing (MPD), which permits a controlled leakage into a secondary absorbent dressing. The study was conducted to compare the MPD-system and Aquacel® (ConvaTec), a hydrofiber wound dressing, which also seems to fulfill all criteria of an ideal donor site dressing.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Last Update Submitted: 2010-01-25
• Study First Posted: 2010-01-26
• Last Update Posted: 2010-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• skin graft donor site anterolateral thigh
• men and women > 18 years

Exclusion Criteria

• informed consent missing
• repeated skin graft take or prior injury at the observed site
• Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
• History of hypersensitivity to the investigational products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MPV	modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK)	-
Aquacel	Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing	-

Primary Outcome Measures

Name	Time	Method
reepithelialization rate	10th day postoperative

Secondary Outcome Measures

Name	Time	Method
pain, scar formation, complications (e.g. infection), costs	pain until and during dressing removal, scar formation 60 days following surgery

Trial Locations

Locations (1)

Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich; 🇩🇪 Munich, Bavaria, Germany