Comparing a new skin treatment to standard methods for skin defects
Official title: Clinical and Histological Study of a Novel Dermal Substitute, NovoSorb® BTM, Used in the Treatment of Full-thickness Skin Defects
Run by University Children's Hospital, Zurich · NCT06255990 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Year to 75 Years |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 4 sites (Aarau, Canton of Aargau and 3 other locations) |
| Status | Recruiting |
| Started | January 15, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | June 2027 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT06255990 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 1 to 70 years with full-thickness skin defects suitable for treatment with the novel dermal substitute.
✕Probably not a fit
Patients with infected wounds or underlying medical conditions that hinder normal wound healing may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies have shown promise in improving skin treatment outcomes, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: sophie.boettcher@kispi.uzh.ch
- Phone: +41442497228
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This trial tests whether Aloe vera gel dressings reduce pain more than paraffin tulle dressings for adults (18–60) after split-thickness skin graft donor-site wounds.
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Lower leg skin grafts after tumour removal: does negative pressure dressings help or not?
This trial tests whether negative pressure wound therapy over split-thickness skin grafts on the lower leg reduces infection compared with traditional dressings in adults after skin tumour removal.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.