A multicenter randomized controlled trial assessing and comparing long-term scar quality after micrografting versus mesh grafting of deep dermal burns
- Conditions
- patients with clinically deep burn or deep skin defect between 4% and 20% TBSA
- Registration Number
- NL-OMON29090
- Lead Sponsor
- niversity Hospital Ghent, Belgium
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
•Patients =18 years
•Clinically deep burn or deep skin defect between 4% and 20% TBSA
•Patients with two comparable deep partial thickness and/or full thickness burns, confirmed by laser Doppler imaging (LDI) or deep skin defects, of minimum 1:2 plissee = 36cm², requiring surgery after assessment by a (plastic) surgeon/burn physician
•Patients who are mentally capable to give legal consent or legal representative when the patient is temporarily incompetent (e.g. patient is sedated/ventilated)
•Patient has participated in another study utilizing an investigational drug or device within the previous 30 days
•Wounds covering face, hands or joints
•Patient has one or more medical condition(s) that in the opinion of the treating physician would make the patient an inappropriate candidate for this study
•Patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ong-term scar quality 12 months after skin transplantation assessed with the Patient and Observer Scar Assessment Scale (POSAS).
- Secondary Outcome Measures
Name Time Method