Management of split-thickness skin graft donor site: An open, prospective, randomized, controlled clinical trial for comparison of three different dressing materials.
Phase 4
- Conditions
- Split-skin grafting donor sites
- Registration Number
- DRKS00030018
- Lead Sponsor
- QRSKIN GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 69
Inclusion Criteria
patients scheduled for elective skin grafting were eligible for inclusion in the study
Exclusion Criteria
age under 18 years, pregnancy / lactation, local infection at planned split-thickness skin grafting donor site, hypersensitivity to dressing components, malignant or autoimmune disease, vasculitis, connective tissue diseases, immune system disorders, chemo-, radio- and immunosuppressive therapy within 30 days prior to study enrolment, systemic corticosteroids (intake > 10mg/day), drug abuse, excessive alcohol consumption, recent participation in other clinical trials within 4 weeks before study enrolment.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)time-to-healing (days until complete re-epithelialisation daily until the 14th postoperative day)<br>2Hollander Wound Evaluation Scale<br>(wound assessment following dressing removal using the validated Hollander Wound Evaluation ScaleEvaluation Scale<br>daily until the 14th postoperative day)<br>3intensity of pain<br>(intensity of pain before, during and after dressing change and at rest/motion using visual analogue scale (0 indicating no pain; 10 indicating unbearable pain)<br>daily until the 14th postoperative day)<br>4extent of subjective dressing handling<br>(extent of subjective dressing handling (ease of use) after dressing changes using a 4-item<br>daily until the 14th postoperative day)<br>
- Secondary Outcome Measures
Name Time Method scar quality at 3, 6 and 12 months following split-thickness skin grafting donor site collection.<br>