NL-OMON29090
Not yet recruiting
Not Applicable
A multicenter randomized controlled trial assessing and comparing long-term scar quality after micrografting versus mesh grafting of deep dermal burns
niversity Hospital Ghent, Belgium0 sites70 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- patients with clinically deep burn or deep skin defect between 4% and 20% TBSA
- Sponsor
- niversity Hospital Ghent, Belgium
- Enrollment
- 70
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Not specified
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