Clinical and Histological Study of a Novel Dermal Substitute

University of Zurich (UZH)

Status: Enrolling

Conditions: Skin Transplantation

Treatments: Other: Standard of care

Study type: Observational

Funder types: Other

Identifiers

NCT06255990

2022-00828

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 1 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

42 participants in 2 patient groups

NovoSorb® BTM and STSG

Description:

Full thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a split-thickness skin graft (STSG) according to clinical routine

Treatment:

Other: Standard of care

STSG alone

Description:

Full thickness skin defect qualifying for coverage with split-thickness skin graft (STSG) alone according to clinical routine

Treatment:

Other: Standard of care