burn wounds scars
Conditions
Interventions
At the start of the operation will be determined by randomisation if skin
stretching or split skin grafting (acute burn wounds) or serial excision (scar
reconstruction category) will be performed. S
Sponsors
Rode Kruis Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Acute Burn wounds or scar reconstructions that require surgical treatment; 2. The defect is too large for direct closure by advancement of the adjacent skin in one operation by standard techniques; 3. Sufficient healthy skin at (at least) one edge of the wound/scar must be available for the stretching procedure.
Exclusion criteria
Exclusion criteria: 1. language barrier; 2. known history of keloid formation; 3. systemic diseases: Diabetes Mellitus, immunodeficiency, arterial insufficiency; 4. local or systemic application of corticosteroids; 5. psychiatric diseases leading to study bias (e.g. automutulation); 6. skin diseases that lead to collagen and/or elastin abnormalities such as Ehlers Danlos; 7. radiated skin; 8. wound located at extremities, exceeding >33% of circumference (acute burn category); 9. scars requiring reconstructive surgery that are not suitable for serial excision 10. wounds that can be closed by excision and primary closure (both categories) or by a local flap such as Z-plasty (scar reconstruction category);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the surface area of the scar after 12 months (measured with a validated objective photographic device) | — |
Secondary
| Measure | Time frame |
|---|---|
| All scars will also be subjected to the scar evaluation protocol after 3 and 12 months by an independent observer for the evaluation of the: - patient and observer scar assessment scale (POSAS); - scar elasticity (Cutometer); - scar vascularisation & pigmentation (DermaSpectrometer); - scar thickness (histopathology, only after 12 months). Patients will also complete the patients part of the POSAS. Punch biopsies are taken for morphometry of dermal architecture (Fourier analysis). During surgery one biopsy is obtained of the normal skin. In the experimental group an additional biopsy is obtained at the end of the stretching procedure in order to be able to compare structure of the dermal matrix and orientation of the collagen fibers. After 1 year, in adults, one biopsy is taken from the scar. The experimental group will undergo one additional biopsy of the formerly stretched skin. | — |
Countries
Netherlands
Outcome results
None listed