patients with clinically deep burn or deep skin defect between 4% and 20% TBSA
Conditions
Interventions
Prior to surgery two comparable (burn) wounds or two equal parts in one (burn) with a minimum size of 36 cm2 will be selected. These wounds will be randomly allocated to the intervention method (micro
Sponsors
University Hospital Ghent, Belgium
Eligibility
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term scar quality 12 months after skin transplantation assessed with the Patient and Observer Scar Assessment Scale (POSAS). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Long-term scar quality 3 and 12 months after skin transplantation - Possible differences in scar quality between micrografting or meshing technique will be assessed 3 months post-operative at the outpatient clinic. Color and pigmentation are objectively measured with the Mexameter or Dermaspectrometer and skin elasticity with the Cutometer. Subjectively assessment of the scar will be conducted by both researcher and patient with the Patient and Observer Scar Assessment Scale (POSAS). 2. Donorsite size and ratio of donorsite size and actual graft size (cm2) - Surface areas will be calculated with a 3D-camera (Woundworks inSight) 3. Take rate of skin grafts - Take rate will be clinically assessed at 8 +/- 2 days and expressed as the percentage of micrografted and meshed graft take 4. Healing time - Clinical assessment of wound healing 14 and 21 days +/- 2 post application expressed as percentage of the total wound surface area healed - Time to complete wound closure where complete wound closure is defined as > 95% re-epithelialization of the wound with the absence of drainage and no longer needing a substantial wound dressing 5. Bacterial load - Wound swabs for semi-quantitative investigation - Semi-quantitative bacteriology in both groups - Percentage of patients within both groups with clinical wound infection requiring systemic antimicrobial therapy. ‘Clinical infection’ is defined as the presence of cellulitis and/or visible purulence and/or lymphangitis combined with one or more of the following: local wound pain/erythema/edema/malodor. 6. Pain - Will be evaluated in the autografted target wounds with help of a Visual Analogue Scale (VAS score) on day 2 post surgery, before and after removal of Surfasoft®/Urgotul in case of meshed skin grafts or plissees in case of micrografting, and thereafter once weekly during the hospitalization period. After hospital discharge pain will be evaluated again at the 3 and 12 months follow ups 7. Number of secondary proc | — |
Contacts
Public ContactDanielle Rijpma
Rode Kruis Ziekenhuis Beverwijk
Outcome results
None listed