Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel
This study has been completed.
Sponsor:
Klinik Bogenhausen
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
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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
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 May 19, 2013