Clinical and Histological Study of a Novel Dermal Substitute

Recruiting

• Conditions: Skin Transplantation
• Interventions: Other: Standard of care

• Registration Number: NCT06255990
• Lead Sponsor: University Children's Hospital, Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-15
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21
• Primary Completion: 2026-06-01
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Age: 1 to 70 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
STSG alone	Standard of care	Full thickness skin defect qualifying for coverage with split-thickness skin graft (STSG) alone according to clinical routine
NovoSorb® BTM and STSG	Standard of care	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

Primary Outcome Measures

Name	Time	Method
Skin elasticity after 1year post-transplantation	1 year post-transplantation	Comparison of skin elasticity of treated skin versus adjacent normal skin

Secondary Outcome Measures

Name	Time	Method
Histological staining	within 1 year after skin transplantation	Histological characterisation of epidermal and dermal components
Change of quality of life within one year after skin transplantation	within 1 year after skin transplantation	Quality of life assessed with standard EuroQoL questionnaire
Skin color assessment	within 1 year after skin transplantation	Changes in skin color
Photographical assessment	within 1 year after skin transplantation	Changes in graft-size
Immunohistochemical analyses	14-21 days after BTM transplantation	Histological characterisation of mature BTM

Trial Locations

Locations (2)

University Children's Hospital Zurich; 🇨🇭 Zürich, Zurich, Switzerland

University Hospital Zurich; 🇨🇭 Zürich, Zurich, Switzerland