Fat Grafting in Skin-grafted Deep Burn Scars

NCT ID: NCT03627650

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2016-10-01

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.

Conditions

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Burn Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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

Study Groups

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1 group of 15 patients

procedure/surgery: fat grafting injection of scar

Group Type EXPERIMENTAL

lipofilling/ fat grafting

Intervention Type PROCEDURE

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

Same group of 15 patients

procedure/surgery: placebo injection of scar

Group Type EXPERIMENTAL

placebo injection

Intervention Type PROCEDURE

Interventions

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lipofilling/ fat grafting

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

Intervention Type PROCEDURE

placebo injection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* early skin-grafted deep burn scars
* otherwise healthy

Exclusion Criteria

* concomitant disease
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Phillip Blondeel

Clinical Professor, Head of Plastic Surgery, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maarten AJ Doornaert, MD

Role: PRINCIPAL_INVESTIGATOR

UGent University Hospital

Other Identifiers

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EC 2010/ 572

Identifier Type: -

Identifier Source: org_study_id

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