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

University Children's Hospital, Zurich4 sites in 1 country42 target enrollmentJanuary 15, 2024

ConditionsSkin Transplantation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Transplantation
Sponsor: University Children's Hospital, Zurich
Enrollment: 42
Locations: 4
Primary Endpoint: Skin elasticity after 1year post-transplantation
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 15, 2024

End Date

June 1, 2027

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Children's Hospital, Zurich

Responsible Party

Sponsor

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
•Adolescent/Adult patients or in case of children their parents/legal representatives having insufficient knowledge of local language
•Pregnant or breast feeding females

Outcomes

Primary Outcomes

Skin elasticity after 1year post-transplantation

Time Frame: 1 year post-transplantation

Comparison of skin elasticity of treated skin versus adjacent normal skin

Secondary Outcomes

Histological staining(within 1 year after skin transplantation)
Change of quality of life within one year after skin transplantation(within 1 year after skin transplantation)
Photographical assessment(within 1 year after skin transplantation)
Skin color assessment(within 1 year after skin transplantation)
Immunohistochemical analyses(14-21 days after BTM transplantation)