Clinical and Histological Study of a Novel Dermal Substitute
NCT ID: NCT06255990
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
42 participants
OBSERVATIONAL
2024-01-15
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NovoSorb® BTM and STSG
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
Standard of care
Standard of care
STSG alone
Full thickness skin defect qualifying for coverage with split-thickness skin graft (STSG) alone according to clinical routine
Standard of care
Standard of care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard of care
Standard of care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
1 Year
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Zurich
OTHER
Kantonsspital Aarau
OTHER
Kantonsspital Winterthur KSW
OTHER
University Children's Hospital, Zurich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sophie Böttcher, MD
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital, Zurich
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cantonal Hospital Aarau
Aarau, Canton of Aargau, Switzerland
University Children's Hospital Zurich
Zurich, Canton of Zurich, Switzerland
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Cantonal Hospital Winterthur
Winterthur, Winterthur, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
jan Plock, Prof. Dr. med.
Role: primary
Sophie Böttcher, MD
Role: primary
Vivienne Woodtli
Role: backup
Bong-Sung Kim, Prof.
Role: primary
Abdul R Jandali, Dr. med.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-00828
Identifier Type: -
Identifier Source: org_study_id