Actively Recruiting
Clinical and Histological Study of a Novel Dermal Substitute
Led by University Children's Hospital, Zurich · Updated on 2026-04-03
42
Participants Needed
4
Research Sites
176 weeks
Total Duration
On this page
Sponsors
U
University Children's Hospital, Zurich
Lead Sponsor
U
University of Zurich
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Clinical and Histological Study of a Novel Dermal Substitute
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 75 years
- Full-thickness skin defect suitable for coverage with NovoSorb4 BTM before skin graft transplantation
- Skin defects from acute cases like burns, soft tissue injuries, or skin necrosis
- Skin defects from reconstructive cases such as scars, congenital nevi, tumor removal, or other surgeries
- Documented medical decision to cover skin defects with either the two-step BTM/skin graft procedure, skin graft alone, or both on different wound areas
- Informed consent given by patients, parents, or legal representatives
You will not qualify if you...
- Infected wounds that require surgery beyond dermal template use
- Known medical conditions interfering with wound healing (e.g., immune deficiency, systemic skin diseases, metabolic defects including diabetes)
- Previous participation in this study
- Inability of adolescent/adult patients or parents/legal representatives of children to comply with the study protocol
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Cantonal Hospital Aarau
Aarau, Canton of Aargau, Switzerland, 5001
Actively Recruiting
2
University Children's Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8032
Actively Recruiting
3
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8090
Actively Recruiting
4
Cantonal Hospital Winterthur
Winterthur, Winterthur, Switzerland, 8400
Actively Recruiting
Research Team
S
Sophie Böttcher, MD
CONTACT
V
Vivienne Woodtli, dipl. med.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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