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

Recruiting now · Phase 3

Conditions studied: Burns

In brief

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.

Key facts

Study ID

NCT06745557

Run by

CUTISS AG

People needed

70

Starts

2024-12-13

Expected to finish

2029-06-30

Last updated by the study team

2026-08-10

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Patients with pre-existing coagulation disorders as defined by international normalised ratio (INR) outside its normal value, a prothrombin time (PT) greater than the upper limit of normal, and fibrinogen less than the lower limit of normal prior to the current hospital admission
• Patients with a history of clinically significant hypersensitivity to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen and it's derivatives (e.g. gelatine)
• Previous treatment with denovoSkin™
• Participation in any clinical interventional study within 60 days prior to the first IMP administration in case of monoclonal antibodies and <30 days for all other IMPs
• Patients unwilling or unable to comply with procedures required in this clinical study protocol
• Pregnant or lactating women
• Women of child-bearing potential not using highly effective method(s) of birth control (i.e., with low failure rate <1% per year) throughout the study and/or unwilling to be tested for pregnancy. A negative serum beta-human chorionic gonadotropin (β-hCG) test is required on the day of grafting
• Patient is the Investigator, one of his/her family members, employees, and other dependent persons

Where it is running

• Universtitätsspital Zürich — Zurich, Switzerland (enrolling)
• Hopital Edouard Herriot Centre des Brûlés de Lyon — Lyon, France (enrolling)
• Pharmacie Hôpital Conception — Marseille, France (enrolling)
• Centre Hospitalier Universitaire de Montpellier — Montpellier, France (enrolling)
• BG Klinikum Unfallkrankenhaus Berlin — Berlin, Germany (enrolling)
• BG Klinikum Bergmannstrost Halle — Halle, Germany (enrolling)
• Hospital Universitatrio y Politécnico La Fe — Valencia, Spain (enrolling)
• CHU de Liège Département de pharmacie hospitalière - Secteur Essais cliniques — Liège, Belgium (enrolling)
• BG-Unfallklinik Murnau — Murnau am Staffelsee, Germany (enrolling)
• Santobono-Pausilipon — Naples, Italy (enrolling)
• Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli — Naples, Italy (enrolling)
• Rode Kruis Ziekenhuis — Beverwijk, Netherlands (enrolling)
• Maasstad Hospital Dep. Burn Wound Centre — Rotterdam, Netherlands (enrolling)
• Samodzielny Zakład Opieki Zdrowotnej z siedzibą w Łęcznej — Łęczna, Poland (enrolling)
• Unidade de Queimados do CHUC — Coimbra, Portugal (enrolling)
• Hospital Universitario Vall d'Hebron — Barcelona, Spain (enrolling)
• Hospital Universitario La Paz Edificio Traumatología — Madrid, Spain (enrolling)
• Medizinische Hochschule Hannover — Hanover, Germany
• AOU Padova — Padova, Italy

Full record on ClinicalTrials.gov

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