Fat Grafting in Skin-grafted Deep Burn Scars
Fat Grafting in Immature Skin-grafted Burn Scars: a Randomised Controlled Clinical Trial
1 other identifier
interventional
15
0 countries
N/A
Brief Summary
fat grafting in human skin-grafted immature burn scars histological, clinical and photographic follow-up
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 6, 2017
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedAugust 21, 2018
August 1, 2018
3.4 years
October 6, 2017
August 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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)
6 months
improvement of scar quality by physiological testing with cutometer
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
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
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)
measures transepidermal water loss; g/m2/h; higher values worse outcome
6 months, 1 year
physiological testing of scar tissue by corneometer
measures hydration of the epidermis; corneometer units, higher values better outcome
6 months, 1 year
Study Arms (2)
1 group of 15 patients
EXPERIMENTALprocedure/surgery: fat grafting injection of scar
Same group of 15 patients
EXPERIMENTALprocedure/surgery: placebo injection of scar
Interventions
liposuction, processing/ cleaning of fat tissue; reinjection with sharp needle transcutaneous
Eligibility Criteria
You may qualify if:
- early skin-grafted deep burn scars
- otherwise healthy
You may not qualify if:
- concomitant disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maarten AJ Doornaert, MD
UGent University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor, Head of Plastic Surgery, Principal Investigator
Study Record Dates
First Submitted
October 6, 2017
First Posted
August 13, 2018
Study Start
May 1, 2013
Primary Completion
September 10, 2016
Study Completion
October 1, 2016
Last Updated
August 21, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share