Fat Grafting in Skin-grafted Deep Burn Scars
- Conditions
- Burn Scar
- Interventions
- Procedure: placebo injectionProcedure: lipofilling/ fat grafting
- Registration Number
- NCT03627650
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
fat grafting in human skin-grafted immature burn scars histological, clinical and photographic follow-up
- Detailed Description
Objective: A randomised clinical trial was performed to determine the effect of autologous fat grafting on scar formation in early skin-grafted deep burn wounds.
Methods: Included patients received split-thickness skin grafting procedures for deep burn wounds less than 3 months ago. A homogenous scar area in each patient was divided into two equal parts. One part was treated with transcutaneous sharp needle autologous fat grafting, the adjacent part with transcutaneous saline injection as control. Results were evaluated by clinical assessment with scar scale questionnaires, histological examination, and objective scar assessment with Cutometer, Mexameter, Tewameter and Corneometer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- early skin-grafted deep burn scars
- otherwise healthy
- concomitant disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Same group of 15 patients placebo injection procedure/surgery: placebo injection of scar 1 group of 15 patients lipofilling/ fat grafting procedure/surgery: fat grafting injection of scar
- Primary Outcome Measures
Name Time Method improvement of scar quality by physiological testing with cutometer 6 months, 1 year measures elasticity of the scar; micrometer; higher values better outcome
Improvement of scar quality by subjective evaluation with numerical Vancouver Scar Scale 1 year numerical score 0 to 13; ranges vascularity, height/thickness, pliability, and pigmentation
Improvement of scar quality by histological assessment 6 months histology of scar tissue, scoring by 2 independent blinded anatomopathologists, (numerical scoring of fibroblast activity, collagen and elastin organisation, vascularity) scoring range min 1(close to normal tissue) - 3 (scar characteristics)
physiological testing of scar tissue by corneometer 6 months, 1 year measures hydration of the epidermis; corneometer units, higher values better outcome
Improvement of scar quality by subjective evaluation with numerical POSAS (Patient and Observer Scar Assessment Scale) Scale 1 year numerical score 5 to 50: VSS plus surface area; patient assessments of pain, itching, color, stiffness, thickness, relief
improvement of scar quality by physiological testing with TEWA-meter (Trans Epidermal Water Loss-meter) 6 months, 1 year measures transepidermal water loss; g/m2/h; higher values worse outcome
- Secondary Outcome Measures
Name Time Method