Overview
The goal of this observational study is to compare a novel dermal substitute to a the current standard procedure in the treatment of full thickness skin defects.
The main questions aim to answer are:
• Is the skin elasticity treated with the novel dermal substitute better than the skin elasticity treated with the current standard procedure Participants skin elasticity will be measured by Cutometer® MPA-580 assessment.
Eligibility
Inclusion Criteria:
- Age: 1 to 70 years
- Full-thickness skin defect qualifying for coverage with the dermal substitute
NovoSorb® BTM before transplantation with a STSG:
- Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans or similar condition
- Reconstructive cases (elective surgery): e.g. scar formation after burn injury, giant congenital nevus, defect after removal of skin tumor, skin defect due to other surgical procedures
- Documented medical treatment decision of covering the full-thickness skin defects with
either the two-step BTM/STSG procedure or with STSG alone or by using both techniques on different wound areas
- Informed consent by patients/parents or other legal representative
Exclusion Criteria:
- Infected wounds needing surgical procedure other than a dermal template
- Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin disease, any kind of congenital defect of metabolism including diabetes)
- Previous enrolment of the patient into the current study
- Adolescent/Adult patients or in case of children their parents/legal representatives unable to comply with the study protocol
- Adolescent/Adult patients or in case of children their parents/legal representatives having insufficient knowledge of local language
- Pregnant or breast feeding females