Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel

This study has been completed.
Sponsor:
Information provided by:
Klinik Bogenhausen
ClinicalTrials.gov Identifier:
NCT01055925
First received: January 25, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Klinik Bogenhausen:

Primary Outcome Measures:
  • reepithelialization rate [ Time Frame: 10th day postoperative ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055925

Locations
Germany
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

No publications provided

ClinicalTrials.gov Identifier: NCT01055925     History of Changes
Other Study ID Numbers: MPV-AQUACEL
Study First Received: January 25, 2010
Last Updated: January 25, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014