Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

Phase 2

Active, not recruiting

• Conditions: Burns
• Interventions: Biological: EHSG-KF; Biological: STSG

• Registration Number: NCT03227146
• Lead Sponsor: CUTISS AG

Brief Summary

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

Detailed Description

This multicentre phase IIb clinical trial will target adults and adolescents 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 Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-24
• Study Start: 2017-10-25
• Primary Completion: 2022-11-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-03-25
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 14

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
• 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)
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Option 1	EHSG-KF	Location A is the experimental area and Location B is the control area.
Option 1	STSG	Location A is the experimental area and Location B is the control area.
Option 2	STSG	Location A is the control area and Location B is the experimental area.
EHSG-KF and STSG Transplantation	EHSG-KF	Transplantation of EHSG-KF to the experimental area and transplantation of STSG (split-thickness skin graft) to the control area
EHSG-KF and STSG Transplantation	STSG	Transplantation of EHSG-KF to the experimental area and transplantation of STSG (split-thickness skin graft) to the control area
Option 2	EHSG-KF	Location A is the control area and Location B is the experimental area.

Primary Outcome Measures

Name	Time	Method
Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface	4 weeks post grafting	Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface area to biopsy site/donor site surface area

Secondary Outcome Measures

Name	Time	Method
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	Assessment of elasticity of experimental area and control area using Cutometer(R)
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	Evaluation of clinical signs of infection at experimental area and control area
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	Evaluation of microbiologic signs of infection at experimental area and control area
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	Assessment of general scar Quality of experimental area and control area using POSAS assessment tool

Trial Locations

Locations (6)

Chirurgia Plastica e Centro Grandi Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli; 🇮🇹 Napoli, Italy

Unità di Chirurgia Plastica e Ustioni Ospedale Santobono; 🇮🇹 Napoli, Italy

Rode Kruis Ziekenhuis; 🇳🇱 Beverwijk, Netherlands

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

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

University Hospital Zurich; 🇨🇭 Zurich, Switzerland