Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel

Reepithelialization of Skin Graft Donor Sites Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055925
• Other study ID #: MPV-AQUACEL
• Status: Completed
• Phase: N/A
• First received: January 25, 2010
• Last updated: January 25, 2010

Study information

• Verified date: January 2010
• Source: Klinik Bogenhausen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Reepithelialization of Skin Graft Donor Sites

Intervention

Device:
• modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK)

• Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Klinik Bogenhausen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reepithelialization rate		10th day postoperative	Yes
Secondary	pain, scar formation, complications (e.g. infection), costs		pain until and during dressing removal, scar formation 60 days following surgery	Yes