NCT01055925

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
Last Updated

January 26, 2010

Status Verified

January 1, 2010

First QC Date

January 25, 2010

Last Update Submit

January 25, 2010

Conditions

Reepithelialization of Skin Graft Donor Sites

Outcome Measures

Primary Outcomes (1)

  • reepithelialization rate

    10th day postoperative

Secondary Outcomes (1)

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

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

Study Arms (2)

MPV

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

Aquacel

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

Interventions

modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK)DEVICE
MPV
Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressingDEVICE
Aquacel

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • skin graft donor site anterolateral thigh
  • men and women \> 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, Bavaria, 81925, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Last Updated

January 26, 2010

Record last verified: 2010-01

Locations

DE(1)