Clinical and Histological Study of a Novel Dermal Substitute

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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Transplantation
• Intervention / Treatment: Other: Standard of care

• Study Type: Observational
• Enrollment (Estimated): 42

Contacts and Locations

• Study Contact: Name: Sophie Böttcher, MD; Phone Number: +41442667111; Email: sophie.boettcher@kispi.uzh.ch
• Study Contact Backup: Name: Vivienne Woodtli; Phone Number: +41442667078; Email: vivenne.woodtli@kispi.uzh.ch

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8032
      • Recruiting
      • University Children's Hospital Zurich
      • Contact: Sophie Böttcher, MD; Phone Number: +41442667111; Email: sophie.boettcher@kispi.uzh.ch
      • Contact: Vivienne Woodtli; Phone Number: +41442667078; Email: vivienne.woodtli@kispi.uzh.ch
      • Principal Investigator: Sophie Böttcher, MD
    • Zürich, Zurich, Switzerland, 8090
      • Recruiting
      • University Hospital Zürich
      • Contact: Bong-Sung Kim, Prof.; Phone Number: +41432538932; Email: bong-sung.kim@usz.ch
      • Principal Investigator: Bong-Sung Kim, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin elasticity after 1year post-transplantation	Comparison of skin elasticity of treated skin versus adjacent normal skin	1 year post-transplantation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Sophie Böttcher, MD, University Children's Hospital, Zurich

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-00828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No