Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children

NCT03229564 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: TBRU-dS-BC-PIIb
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 4

Brief Summary

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns.

Conditions

Burns

Keywords

Burns; Scar; Skin; Wound healing; Tissue Engineering; Dermis; Epidermis; Thermal Injuries

Outcome Measures

Primary Outcomes (1)

• Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface

  Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface area to biopsy site/donor site surface area

  4 weeks post grafting

Secondary Outcomes (4)

• Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection

  4-11 days post grafting and 21 +/-2 days post grafting

• Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection

  4-11 days post grafting and 21 +/-2 days post grafting

• Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R)

  1 year +/-30 days post grafting

• Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by assessment of general scar quality using POSAS assessment tool

  1 year +/-30 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: 0 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: \<12 years of age
• Deep partial thickness and/or full-thickness burns requiring surgical wound coverage
• 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
• Patients with a known history of malignancy
• 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 or parents/legal guardian expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
• Pregnant or breast feeding females
• Suspicion of child abuse
• Wounds in the head and neck area as study target area (only applicable for study patients in The Netherlands)
• 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 (4)

Dipartimento di Chirurgia Pediatrica Ospedale dei bambini Vittorio Buzzi

Milan, Italy

Location

Unità di Chirurgia Plastica e Ustioni Ospedale Santobono

Napoli, Italy

Location

Rode Kruis Ziekenhuis

Beverwijk, 1940, Netherlands

Location

University Children's Hospital Zurich

Zurich, 8032, 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

Burns; Cicatrix

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clemens Schiestl, 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: July 7, 2017
• First Posted: July 25, 2017
• Study Start: October 25, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); NL (1); IT (2)