Clinical and Histological Study of a Novel Dermal Substitute

Clinical and Histological Study of a Novel Dermal Substitute, NovoSorb® BTM, Used in the Treatment of Full-thickness Skin Defects

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.

Inclusion Criteria:

• Age: 1 to 75 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
• Pregnant or breast feeding females