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

A Phase IIb, Prospective, Intra-patient Randomised Controlled, Multicentre Study to Evaluate the Safety and Efficacy of an Autologous Bio-engineered Dermo-epidermal Skin Substitute (EHSG-KF) for the Treatment of Partial Deep Dermal and Full Thickness Burns in Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)

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.

Study Overview

• Status: Recruiting
• Conditions: Burns
• Intervention / Treatment: Biological: EHSG-KF; Biological: STSG

Detailed Description

This multicentre phase IIb clinical trial will target patients from 1-17 years with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. Particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed STSG.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy
    • Recruiting
    • Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
  • Padova, Italy
    • Recruiting
    • U.O.C. Grandi Ustionati Azienda Ospedale Università Padova
  • Torino, Italy, 10126
    • Not yet recruiting
    • Città della Salute
  • Verona, Italy
    • Not yet recruiting
    • U.O. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera Universitaria Integrata Verona
    • Principal Investigator: Jasminka Minic
• Netherlands
  • Beverwijk, Netherlands, 1940
    • Recruiting
    • Rode Kruis Ziekenhuis
• Switzerland
  • Zurich, Switzerland, 8032
    • Recruiting
    • University Children's Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: <12 years of age
• Deep partial thickness and/or full-thickness burns requiring surgical wound coverage
• Expected that ≥90 cm2 of wound (not counting the head and neck area for study patients in The Netherlands) will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care. >20% TBSA burns can be taken as guideline, but TBSA is not an inclusion criterion.
• Signed Informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EHSG-KF and STSG Transplantation; Transplantation of EHSG-KF to the experimental area and transplantation of STSG (split-thickness skin graft) to the control area	Biological: EHSG-KF; Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area; Other Names: denovoSkin; Biological: STSG; Transplantation of autologous split-thickness skin graft to the control area; Other Names: Split-thickness skin graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection	Evaluation of clinical signs of infection at experimental area and control area	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	Evaluation of microbiologic signs of infection at experimental area and control area	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)	Assessment of elasticity of experimental area and control area 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	Assessment of general scar quality of experimental area and control area using POSAS assessment tool	1 year +/-30 days post grafting

Collaborators and Investigators

• Sponsor: CUTISS AG
• Collaborators: University of Zurich; University Hospital, Zürich; Julius Clinical; Sintesi Research Srl; Wyss Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2017
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (ACTUAL): July 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Epidermis; Wound healing; Skin; Burns; Scar; Dermis; Tissue Engineering; Thermal Injuries
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: TBRU-dS-BC-PIIb

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