Clinical and Histological Study of a Novel Dermal Substitute

NCT06255990 | Recruiting

• 1 other identifier: 2022-00828
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 4

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.

Conditions

Skin Transplantation

Outcome Measures

Primary Outcomes (1)

• Skin elasticity after 1year post-transplantation

  Comparison of skin elasticity of treated skin versus adjacent normal skin

  1 year post-transplantation

Secondary Outcomes (5)

• Histological staining

  within 1 year after skin transplantation

• Skin color assessment

  within 1 year after skin transplantation

• Photographical assessment

  within 1 year after skin transplantation

• Change of quality of life within one year after skin transplantation

  within 1 year after skin transplantation

• Immunohistochemical analyses

  14-21 days after BTM transplantation

Study Arms (2)

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

Other: Standard of care

STSG alone

Full thickness skin defect qualifying for coverage with split-thickness skin graft (STSG) alone according to clinical routine

Other: Standard of care

Interventions

Standard of care OTHER

Standard of care

NovoSorb® BTM and STSG; STSG alone

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The project population will consist of children and adults that received surgical coverage of full-thickness skin defects either the two-step BTM/STSG procedure or with STSG alone under routine conditions.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead
• University of Zurich: collaborator
• Kantonsspital Aarau: collaborator
• Kantonsspital Winterthur KSW: collaborator

Study Sites (4)

Cantonal Hospital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

University Hospital Zurich

Zurich, Canton of Zurich, 8090, Switzerland

RECRUITING

Cantonal Hospital Winterthur

Winterthur, Winterthur, 8400, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Punch biopsies

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sophie Böttcher, MD

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Böttcher, MD

CONTACT

+41442497228; sophie.boettcher@kispi.uzh.ch

Vivienne Woodtli, dipl. med.

CONTACT

+41442497586; vivenne.woodtli@kispi.uzh.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 13, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)