Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children

NCT03394612 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: TBRU-dS-RAC-PII
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 7

Brief Summary

This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.

Conditions

Skin Wound

Keywords

Scar; Skin; Wound Healing; Tissue Engineering; Dermis; Epidermis

Outcome Measures

Primary Outcomes (1)

• Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality

  Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality, using the POSAS ("Patient and Observer Scar Assessment Scale"). The reported Observer Total Score can range from 1 (best) to 10 (worst).

  3 months post grafting

Secondary Outcomes (12)

• Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality

  3 months and 1 year +/- 30 days post grafting

• Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality

  3 months and 1 year +/- 30 days post grafting

• Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality

  3 months and 1 year +/- 30 days post grafting

• A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality

  3 months and 1 year +/- 30 days post grafting

• Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation

  28 +/- 3 days post grafting

Study Arms (2)

Option 1

OTHER

Location A is the experimental area and Location B is the control area.

Biological: EHSG-KF; Biological: STSG

Option 2

OTHER

Location A is the control area and Location B is the experimental area.

Biological: EHSG-KF; Biological: STSG

Interventions

EHSG-KF BIOLOGICAL

Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area

Also known as: denovoSkin

Option 1; Option 2

STSG BIOLOGICAL

Transplantation of autologous split-thickness skin graft to the control area

Also known as: Split-thickness skin graft

Option 1; Option 2

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥1 years of age
• Large full-thickness defects that require coverage after excision of: Scars, Benign skin tumors (e.g. neurofibroma), Melanocytic nevus (e.g. giant nevus), Gender reassignment surgery, Soft tissue defect after trauma, Soft tissue defect after infection and debridement (e.g necrotizingn fascitis, hidadentitis suppurativa, purpura fulminans), Flap donorsite (e.g. radial forearm flap)
• Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): 1-5 years: minimum 9cm2, 6-16 years: minimum 25cm2, \>16 years: minimum 45cm2
• Signed Informed consent

You may not qualify if:

• Patients tested positive for HBV, HCV, syphilis or HIV
• Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing)
• Severe drug and alcohol abuse
• Pre-existing coagulation disorders as defined by INR outside its normal value, PTT \>ULN and fibrinogen \<LLN prior to the current hospital admission and / or at the Investigator's discretion
• Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen
• Previous enrolment of the patient into the current phase II study
• Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study
• Patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
• Pregnant or breast feeding females
• Intention to become pregnant during the clinical course of the study (12 months)
• Enrolment of the Investigator, his/her family members, employees and other dependent persons

Sponsors & Collaborators

• CUTISS AG: lead
• Wyss Zurich: collaborator
• Julius Clinical: collaborator
• Sintesi Research Srl: collaborator
• University Hospital, Zürich: collaborator
• University of Zurich: collaborator

Study Sites (7)

Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli

Napoli, Italy

Location

Unità di Chirurgia Plastica e Ustioni Ospedale Santobono

Napoli, Italy

Location

U.O.C. Grandi Ustionati Azienda Ospedale Università Padova

Padua, Italy

Location

Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center

Amsterdam, 1081, Netherlands

Location

Rode Kruis Ziekenhuis

Beverwijk, 1940, Netherlands

Location

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Schiestl C, Neuhaus K, Meuli M, Farkas M, Hartmann-Fritsch F, Elrod J, Bressan J, Reichmann E, Bottcher-Haberzeth S. Long-Term Outcomes of a Cultured Autologous Dermo-Epidermal Skin Substitute in Children: 5-Year Results of a Phase I Clinical Trial. J Burn Care Res. 2025 Mar 4;46(2):326-334. doi: 10.1093/jbcr/irae150.

  PMID: 39115183 DERIVED

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clemens Sc, Prof.

  University Children's Hospital, Zurich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: January 9, 2018
• Study Start: February 14, 2018
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); IT (3); CH (2)