Fat Grafting in Skin-grafted Deep Burn Scars

Study Overview
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Brief Summary
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fat grafting in human skin-grafted immature burn scars histological, clinical and photographic follow-up

Detailed Description
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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.

Official Title
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Fat Grafting in Immature Skin-grafted Burn Scars: a Randomised Controlled Clinical Trial

Conditions
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Burn Scar

Intervention / Treatment
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* Procedure: lipofilling/ fat grafting
* Procedure: placebo injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: early skin-grafted deep burn scars otherwise healthy Exclusion Criteria: concomitant disease

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 group of 15 patients<br>procedure/surgery: fat grafting injection of scar | Procedure: lipofilling/ fat grafting<br>* liposuction, processing/ cleaning of fat tissue; reinjection with sharp needle transcutaneous<br>|
| Experimental: Same group of 15 patients<br>procedure/surgery: placebo injection of scar | Procedure: placebo injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of scar quality by histological assessment | 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) | 6 months | 
| improvement of scar quality by physiological testing with cutometer | measures elasticity of the scar; micrometer; higher values better outcome | 6 months, 1 year | 
| Improvement of scar quality by subjective evaluation with numerical Vancouver Scar Scale | numerical score 0 to 13; ranges vascularity, height/thickness, pliability, and pigmentation | 1 year | 
| Improvement of scar quality by subjective evaluation with numerical POSAS (Patient and Observer Scar Assessment Scale) Scale | numerical score 5 to 50: VSS plus surface area; patient assessments of pain, itching, color, stiffness, thickness, relief | 1 year | 
| improvement of scar quality by physiological testing with TEWA-meter (Trans Epidermal Water Loss-meter) | measures transepidermal water loss; g/m2/h; higher values worse outcome | 6 months, 1 year | 
| physiological testing of scar tissue by corneometer | measures hydration of the epidermis; corneometer units, higher values better outcome | 6 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burn, scar, fat, grafting