(brand)wonden burns and other skin defects
Conditions
Interventions
Prior to surgery two comparable (burn) wounds or two equal parts in one (burn)
with a minimum size of 36 cm2 per wound will be selected. These wounds will be
randomly allocated to the intervention m
Sponsors
Universitair Ziekenhuis Gent
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years and older - deep burn or deep skin defect requiring skin grafting - two comparable deep partial and/or full thickness burns, confirmed with Laser Doppler Imaging, or deep skin defect, of a minimum of 36 cm2 per wound, requiring skin grafting after assessment of a (plastic) surgeon/burn physician - mentally capable to give legal consent or legal representative when patient is (temporarily) incompetent (e.g. sedated/ventilated)
Exclusion criteria
Exclusion criteria: - patient has participated in another study utilizing an investigational drug or device within 30 days - wounds covering face, hands or joints - patient has one or more medical condition(s) that in the opinion of treating physician would make the patient an inappropriate candidate for this study - patient who is expected (according to the responsible physician) to be non-compliant to study protocol. (This includes patients with severe cognitive dysfunction/impairment and sever 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 up | — |
Countries
Netherlands
Outcome results
None listed