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Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel

This study has been completed.
Information provided by:
Klinik Bogenhausen Identifier:
First received: January 25, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
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.

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

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Further study details as provided by Klinik Bogenhausen:

Primary Outcome Measures:
  • reepithelialization rate [ Time Frame: 10th day postoperative ]

Secondary Outcome Measures:
  • pain, scar formation, complications (e.g. infection), costs [ Time Frame: pain until and during dressing removal, scar formation 60 days following surgery ]

Arms Assigned Interventions
Active Comparator: MPV Device: modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK)
Active Comparator: Aquacel Device: Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01055925

Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich
Munich, Bavaria, Germany, 81925
Sponsors and Collaborators
Klinik Bogenhausen
  More Information Identifier: NCT01055925     History of Changes
Other Study ID Numbers: MPV-AQUACEL
Study First Received: January 25, 2010
Last Updated: January 25, 2010

Additional relevant MeSH terms:
Carboxymethylcellulose Sodium
Gastrointestinal Agents processed this record on May 22, 2017