Clinical and Histological Study of a Novel Dermal Substitute
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of care.
- Who it may be relevant to
- Registry conditions: Skin Transplantation. Basic parameters: 1 year — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical and Histological Study of a Novel Dermal Substitute, NovoSorb® BTM, Used in the Treatment of Full-thickness Skin Defects
Overview
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.
Interventions
- Other Standard of care
Standard of care
Primary outcome measures
- Skin elasticity after 1year post-transplantation [Time frame: 1 year post-transplantation]
Secondary outcome measures (5)
- Histological staining [Time frame: within 1 year after skin transplantation]
- Skin color assessment [Time frame: within 1 year after skin transplantation]
- Photographical assessment [Time frame: within 1 year after skin transplantation]
- Change of quality of life within one year after skin transplantation [Time frame: within 1 year after skin transplantation]
- Immunohistochemical analyses [Time frame: 14-21 days after BTM transplantation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 4 centers
- Cantonal Hospital Aarau — Aarau
- University Children's Hospital Zurich — Zurich
- University Hospital Zurich — Zurich
- Cantonal Hospital Winterthur — Winterthur
Identifiers
NCT: NCT06255990 · 2022-00828