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
About this trial
This is an interventional treatment trial for Burn Scar focused on measuring burn, scar, fat, grafting
Eligibility Criteria
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
NCT ID
NCT03627650
First Posted
October 6, 2017
Last Updated
August 18, 2018
Sponsor
University Hospital, Ghent
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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