Skip to main content
OpenTrials
Completed

NCT Number: NCT03627650

Fat Grafting in Skin-grafted Deep Burn Scars

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Burn Scar Burns Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Platelet Glycoprotein IV Deficiency Wounds and Injuries

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • early skin-grafted deep burn scars
  • otherwise healthy

Exclusion criteria

  • concomitant disease

Treatment and study plan

lipofilling/ fat grafting

Procedure

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

placebo injection

Procedure

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. physiological testing of scar tissue by corneometer

    Time frame: 6 months, 1 year

    measures hydration of the epidermis; corneometer units, higher values better outcome

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 13, 2018
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.