Fat Grafting in Skin-grafted Deep Burn Scars

August 18, 2018 updated by: Phillip Blondeel, University Hospital, Ghent

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • early skin-grafted deep burn scars
  • otherwise healthy

Exclusion Criteria:

  • concomitant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months
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
6 months, 1 year
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
1 year
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
1 year
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 months, 1 year
physiological testing of scar tissue by corneometer
Time Frame: 6 months, 1 year
measures hydration of the epidermis; corneometer units, higher values better outcome
6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Maarten AJ Doornaert, MD, UGent University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

September 10, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

August 10, 2018

First Posted (Actual)

August 13, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 18, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC 2010/ 572

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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