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OpenTrials
Completed

NCT Number: NCT01055925

Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel

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.

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Key information

Conditions

Reepithelialization of Skin Graft Donor Sites

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich

Munich, Bavaria, 81925, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Device

Primary outcomes

  1. reepithelialization rate

    Time frame: 10th day postoperative

Secondary outcomes

  1. pain, scar formation, complications (e.g. infection), costs

    Time frame: pain until and during dressing removal, scar formation 60 days following surgery

Sponsors and collaborators

Lead sponsor

Klinik Bogenhausen

Other

Registry information

Important dates

First posted
Jan 26, 2010
Registry last updated
Jan 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.