About this trial

This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with deep partial or full-thickness thermal burns of ≥20% total body surface area (TBSA) for which excision and standard of care (SOC) (STSG) are clinically indicated

Patients of either sex aged ≥12 years

Signed informed consent from the patient and/or legally authorised representative

Disqualifiers

Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head/neck)

Patients eligible to have all areas autografted in a single surgery or significantly earlier than the end of the manufacturing period of denovoSkin™, for whom the application of denovoSkin™ would delay the standard of care therapies

Patients with serologic evidence of active hepatitis B virus (HBV) infection (i.e., positive for Hepatitis B surface antigen [HbsAg] or immunoglobulin M total hepatitis B core antibody [anti-HBc]), active hepatitis C infection (hepatitis C virus [HCV] antibody positive), positive human immunodeficiency virus (HIV) serology, or positive Treponema pallidum serology assessed as per local standard of care; cured hepatitis C (defined as documented treatment and negative viral load) is not an exclusion

Patients with known underlying or concomitant medical conditions that, in the opinion of the Investigator, has the potential to significantly delay wound healing, e.g., glycated haemoglobin (HbA1c) ≥53 mmol/mol and/or systemic skin and connective tissue diseases

Trial design

Design model

Single group

Treatments tested in this trial

denovoSkin(TM)
Biological/Vaccine
Transplantation of autologous dermo-epidermal skin substitute denovoSkin(TM) to the experimental area
STSG
Other intervention
Transplantation of autologous split-thickness skin to the control area

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Option 1Other 2 interventions

Group B: Option 2Other 2 interventions

Trial outcomes

Primary outcomes

1

A composite endpoint whereby success is defined by meeting both of the following criteria: - Wound closure - Scar quality (POSAS v2.0)

A composite endpoint whereby success is defined by meeting both of the following criteria: * Wound closure * Scar quality (POSAS v2.0)

Time frame

6 months post grafting

Secondary outcomes

1

Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting

Time frame

4 weeks

2

Assessment of scar contracture

Time frame

6 months post grafting

3

Epithelialisation percentage at 3 months and 6 months post-grafting

Time frame

3 months and 6 months post-grafting

4

Graft take at 14 and 21 days post-grafting

Time frame

14 and 21 days post-grafting

Other outcomes

1

Assessment of safety and tolerability using the National Cancer Institute-CTCAE v5.0 throughout the study: - Assessment of the incidence of treatment-emergent adverse events (TEAEs), total AEs, and serious adverse events (SAEs)

Assessment of safety and tolerability using the National Cancer Institute-CTCAE v5.0 throughout the study: \- Assessment of the incidence of treatment-emergent adverse events (TEAEs), total AEs, and serious adverse events (SAEs)

Time frame

24 months

Locations19

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Belgium

France

Germany

Italy

Netherlands

Poland

Portugal

Spain

Switzerland

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts