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Fat Grafting in Skin-grafted Deep Burn Scars

Primary Purpose

Burn Scar

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lipofilling/ fat grafting
placebo injection
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Scar focused on measuring burn, scar, fat, grafting

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • early skin-grafted deep burn scars
  • otherwise healthy

Exclusion Criteria:

  • concomitant disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1 group of 15 patients

    Same group of 15 patients

    Arm Description

    procedure/surgery: fat grafting injection of scar

    procedure/surgery: placebo injection of scar

    Outcomes

    Primary Outcome Measures

    Improvement of scar quality by histological assessment
    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)
    improvement of scar quality by physiological testing with cutometer
    measures elasticity of the scar; micrometer; higher values better outcome
    Improvement of scar quality by subjective evaluation with numerical Vancouver Scar Scale
    numerical 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) Scale
    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)
    measures transepidermal water loss; g/m2/h; higher values worse outcome
    physiological testing of scar tissue by corneometer
    measures hydration of the epidermis; corneometer units, higher values better outcome

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2017
    Last Updated
    August 18, 2018
    Sponsor
    University Hospital, Ghent
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03627650
    Brief Title
    Fat Grafting in Skin-grafted Deep Burn Scars
    Official Title
    Fat Grafting in Immature Skin-grafted Burn Scars: a Randomised Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2013 (Actual)
    Primary Completion Date
    September 10, 2016 (Actual)
    Study Completion Date
    October 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Ghent

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burn Scar
    Keywords
    burn, scar, fat, grafting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomised controlled trial
    Masking
    ParticipantOutcomes 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
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1 group of 15 patients
    Arm Type
    Experimental
    Arm Description
    procedure/surgery: fat grafting injection of scar
    Arm Title
    Same group of 15 patients
    Arm Type
    Experimental
    Arm Description
    procedure/surgery: placebo injection of scar
    Intervention Type
    Procedure
    Intervention Name(s)
    lipofilling/ fat grafting
    Intervention Description
    liposuction, processing/ cleaning of fat tissue; reinjection with sharp needle transcutaneous
    Intervention Type
    Procedure
    Intervention Name(s)
    placebo injection
    Primary Outcome Measure Information:
    Title
    Improvement of scar quality by histological assessment
    Description
    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)
    Time Frame
    6 months
    Title
    improvement of scar quality by physiological testing with cutometer
    Description
    measures elasticity of the scar; micrometer; higher values better outcome
    Time Frame
    6 months, 1 year
    Title
    Improvement of scar quality by subjective evaluation with numerical Vancouver Scar Scale
    Description
    numerical score 0 to 13; ranges vascularity, height/thickness, pliability, and pigmentation
    Time Frame
    1 year
    Title
    Improvement of scar quality by subjective evaluation with numerical POSAS (Patient and Observer Scar Assessment Scale) Scale
    Description
    numerical score 5 to 50: VSS plus surface area; patient assessments of pain, itching, color, stiffness, thickness, relief
    Time Frame
    1 year
    Title
    improvement of scar quality by physiological testing with TEWA-meter (Trans Epidermal Water Loss-meter)
    Description
    measures transepidermal water loss; g/m2/h; higher values worse outcome
    Time Frame
    6 months, 1 year
    Title
    physiological testing of scar tissue by corneometer
    Description
    measures hydration of the epidermis; corneometer units, higher values better outcome
    Time Frame
    6 months, 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: early skin-grafted deep burn scars otherwise healthy Exclusion Criteria: concomitant disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maarten AJ Doornaert, MD
    Organizational Affiliation
    UGent University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Fat Grafting in Skin-grafted Deep Burn Scars

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