The application of Glyaderm for skin restoration intends to provide a more stable wound closure with enhanced pliability and function of the skin and a more favourable scar. The dermal substitute would be affordable for widespread application in full thickness skin defects and burns. Patients with burn wounds or large full thickness wounds will be evaluated before enrollment. All burn wounds that are not clearly full thickness on clinical assessment will be treated during the first 48 hours with a hydrocolloid paste and covered with a paraffin gauze dressing. This hydrocolloid paste combined with paraffin gauze will ensure maintenance of a moist wound environment for the first 48 hours prior to assessment by LDI and randomization. This is the standard treatment for all burns admitted to the Ghent Burn Centre. Wounds will be photographed on a daily basis. In order to obtain an optimal preparation for LDI, the burn wounds will be meticulously debrided during dressing changes. LDI is most reliable between 48-72 hours. Patients whose burn wounds meet the inclusion criteria, i.e. full thickness burns with LDI values \< 200 will be randomized to receive either GLYADERM and split skin graft versus split skin graft alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Full thickness defects treated with Glyaderm and split skin graft.
Full thickness defects treated with split skin graft alone.
University Hospital Ghent
Ghent, Belgium
Comparison of healing time and percentage of autograft survival
Time frame: After one week
Comparison in bacterial control in full thickness defects
Time frame: On day 3,5 an 7 post application of Glyaderm
To assess the monitoring of dermal substitute ingrowth with Laser Doppler Imaging
Time frame: On day 3, 5 and 7 post application of Glyaderm
To evaluate the functional and cosmetic outcome of skin restoration of full thickness defects treated with Glyaderm and split skin graft versus split skin graft alone
Time frame: 1 month, 3, 6 and 12 months post wound closure
Cost-effectiveness and Health related quality of life (i.e. cost utility analysis)
Time frame: 1 month, 3, 6 and 12 months post wound closure
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