Fat Grafting in Immature Skin-grafted Burn Scars: a Randomised Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 15
- Primary Endpoint
- improvement of scar quality by physiological testing with cutometer
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
2 skin zones per participant, A and B, 1 is treated, 1 is placebo coin toss determines which zone will be treated, this information is kept in sealed envelope
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •early skin-grafted deep burn scars
- •otherwise healthy
Exclusion Criteria
- •concomitant disease
Arms & Interventions
1 group of 15 patients
procedure/surgery: fat grafting injection of scar
Intervention: lipofilling/ fat grafting (Procedure)
Same group of 15 patients
procedure/surgery: placebo injection of scar
Intervention: placebo injection (Procedure)
Outcomes
Primary Outcomes
improvement of scar quality by physiological testing with cutometer
Time Frame: 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
Time Frame: 1 year
numerical score 0 to 13; ranges vascularity, height/thickness, pliability, and pigmentation
Improvement of scar quality by histological assessment
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 6 months, 1 year
measures transepidermal water loss; g/m2/h; higher values worse outcome
Secondary Outcomes
No secondary outcomes reported
Investigators
Phillip Blondeel
Clinical Professor, Head of Plastic Surgery, Principal Investigator
University Hospital, Ghent