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

Burns Clinical Trial

Official title:

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 Adults and Adolescents in Comparison to Autologous Split-thickness Skin Grafts (STSG)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03227146
• Other study ID #: TBRU-dS-BA-PIIb
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: October 25, 2017
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: CUTISS AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: August 31, 2025
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Biological:
• EHSG-KF
Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area
• STSG
Transplantation of autologous split-thickness skin graft to the control area

Locations

Country	Name	City	State
Italy	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	U.O.C. Grandi Ustionati Azienda Ospedale Università Padova	Padova
Italy	Città della Salute	Torino
Italy	U.O. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera Universitaria Integrata Verona	Verona
Netherlands	Rode Kruis Ziekenhuis	Beverwijk
Netherlands	Maasstad Ziekenhuis	Rotterdam
Switzerland	University Children's Hospital Zurich	Zurich
Switzerland	University Hospital Zurich	Zurich

Sponsors (6)

Lead Sponsor	Collaborator
CUTISS AG	Julius Clinical, Sintesi Research Srl, University Hospital, Zürich, University of Zurich, Wyss Zurich

Countries where clinical trial is conducted

Italy,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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