Skip to content

Fat Grafting in Skin-grafted Deep Burn Scars

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03627650
Enrollment
15
Registered
2018-08-13
Start date
2013-05-01
Completion date
2016-10-01
Last updated
2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Scar

Keywords

burn, scar, fat, grafting

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.

Interventions

PROCEDURElipofilling/ fat grafting

liposuction, processing/ cleaning of fat tissue; reinjection with sharp needle transcutaneous

PROCEDUREplacebo injection

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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

Intervention model description

randomised controlled trial

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* early skin-grafted deep burn scars * otherwise healthy

Exclusion criteria

* concomitant disease

Design outcomes

Primary

MeasureTime frameDescription
Improvement of scar quality by histological assessment6 monthshistology 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)
improvement of scar quality by physiological testing with cutometer6 months, 1 yearmeasures elasticity of the scar; micrometer; higher values better outcome
Improvement of scar quality by subjective evaluation with numerical Vancouver Scar Scale1 yearnumerical score 0 to 13; ranges vascularity, height/thickness, pliability, and pigmentation
Improvement of scar quality by subjective evaluation with numerical POSAS (Patient and Observer Scar Assessment Scale) Scale1 yearnumerical 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 yearmeasures transepidermal water loss; g/m2/h; higher values worse outcome
physiological testing of scar tissue by corneometer6 months, 1 yearmeasures hydration of the epidermis; corneometer units, higher values better outcome

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026