Comparing a new skin treatment to standard methods for skin defects

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

This study is testing a new skin treatment to see if it works better than the usual methods for people with serious skin issues that need repair.

Quick facts

• Study type: Observational
• Enrollment: 42 (estimated)
• Ages: 1 Year to 75 Years
• Sex: All
• Sponsor: University Children's Hospital, Zurich (Academic / other)
• Locations: 4 sites (Aarau, Canton of Aargau and 3 other locations)
• Trial ID: NCT06255990 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of a novel dermal substitute, NovoSorb® BTM, in treating full-thickness skin defects compared to the current standard procedure. The primary focus is on measuring skin elasticity using the Cutometer® MPA-580 assessment. Participants will include individuals with various acute and reconstructive skin conditions that require coverage with a dermal substitute before skin transplantation. The study will gather data on the outcomes of both treatment approaches to determine any differences in skin elasticity.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 1 to 70 years with full-thickness skin defects suitable for treatment with the novel dermal substitute.

Not a fit: Patients with infected wounds or underlying medical conditions that hinder normal wound healing may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved healing and skin quality for patients with full-thickness skin defects.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving skin treatment outcomes, suggesting potential for success.

Eligibility criteria

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

Where this trial is running

Aarau, Canton of Aargau and 3 other locations

• Cantonal Hospital Aarau — Aarau, Canton of Aargau, Switzerland (Recruiting)
• University Children's Hospital Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
• University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
• Cantonal Hospital Winterthur — Winterthur, Winterthur, Switzerland (Recruiting)

Study contacts

• Principal investigator: Sophie Böttcher, MD — University Children's Hospital, Zurich
• Study coordinator: Sophie Böttcher, MD

Conditions Skin Transplantation