An interventional study of lipofilling/ fat grafting and placebo injection in Burn Scar, sponsored by University Hospital, Ghent. Completed. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-21.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
fat grafting in human skin-grafted immature burn scars histological, clinical and photographic follow-up
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.
307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.
This study's enrollment of 15 is below the median of 39 across 251 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
procedure/surgery: fat grafting injection of scar
Procedure: lipofilling/ fat grafting
procedure/surgery: placebo injection of scar
Procedure: placebo injection
liposuction, processing/ cleaning of fat tissue; reinjection with sharp needle transcutaneous
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)
Time frame: 6 months
improvement of scar quality by physiological testing with cutometer
measures elasticity of the scar; micrometer; higher values better outcome
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months, 1 year
physiological testing of scar tissue by corneometer
measures hydration of the epidermis; corneometer units, higher values better outcome
Time frame: 6 months, 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent