Burn scars fibrosis hypertrophic skin
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients seen by the plastic surgeon in Burn Centre Beverwijk or Groningen with adherent scars caused by burns, necrotic fasciitis or degloving injury with no history of prior surgical treatment of the scar, other than skin transplantation. - Minimum age of 18 - Patient has an adherent scar (minimum scar age: 12 months) caused by burns, necrotic fasciitis or degloving injury, for which fat grafting is indicated - Competent adults
Exclusion criteria
Exclusion criteria: - Previous scar treatment with fat grafting in selected scar - General exclusion criteria for fat grafting procedure: pregnancy, BMI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter is change in scar pliability, measured by the Cutometer Skin Elasticity Meter 575 (Courage and Khazaka GmbH, Cologne, Germany) between pre- and 12 months post grafting. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in scar pliability, retraction, elasticity, viscoelasticity and maximum extension between pre- and 3 months and 3- and 12 months post SVF enriched grafting will be analysed. Change in retraction, elasticity, viscoelasticity and maximum extension will also be analysed between pre- and 12 months post grafting. Change in the quantity of melanin and erythema will be measured with the DSM II ColorMeter (Cortex Technology, Hadsund, Denmark) immediately before (i.e. within 24 hours before treatment) and at 3 and 12 months post grafting. Change in quantity of melanin and erythema will be analysed between pre- and 3 months post grafting and between 3 months and 12 months post grafting. Change in scar quality will be measured with the Patient and Observer Scar Assessment Scale (POSAS), immediately before (i.e. within 24 hours before treatment) and at 3 and 12 months post grafting. Changes in the POSAS Patient and Observer scale will be analysed between pre- and 3 months post grafting and between 3 months and 12 months post grafting. Histological changes of the scar are objectified by taking 2 mm biopsies of the dermal fat on fixed positions, just before treatment and at 12 months follow up. For patients to participate in our research, this histological part is optional. Histological observation will focus on extracellular matrix remodelling, epidermis renewal, cell infiltration and new microvasculature formation. | — |
Countries
Netherlands