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Fat Grafting in Skin-grafted Deep Burn Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627650
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Phillip Blondeel, University Hospital, Ghent

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

Condition or disease Intervention/treatment Phase
Burn Scar Procedure: lipofilling/ fat grafting Procedure: placebo injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised controlled trial
Masking: Double (Participant, 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
Primary Purpose: Treatment
Official Title: Fat Grafting in Immature Skin-grafted Burn Scars: a Randomised Controlled Clinical Trial
Actual Study Start Date : May 1, 2013
Actual Primary Completion Date : September 10, 2016
Actual Study Completion Date : October 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Scars

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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • early skin-grafted deep burn scars
  • otherwise healthy

Exclusion Criteria:

  • concomitant disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627650


Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Maarten AJ Doornaert, MD UGent University Hospital
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Responsible Party: Phillip Blondeel, Clinical Professor, Head of Plastic Surgery, Principal Investigator, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03627650    
Other Study ID Numbers: EC 2010/ 572
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Phillip Blondeel, University Hospital, Ghent:
burn
scar
fat
grafting
Additional relevant MeSH terms:
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Cicatrix
Burns
Wounds and Injuries
Fibrosis
Pathologic Processes