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

Cutiss

Status and phase: Active, not recruiting; Phase 2

Conditions: Burns

Treatments: Biological: STSG; Biological: EHSG-KF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03229564

TBRU-dS-BC-PIIb

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Option 1

Other group

Description:

Location A is the experimental area and Location B is the control area.

Treatment:

Biological: EHSG-KF

Biological: STSG

Option 2

Other group

Description:

Location A is the control area and Location B is the experimental area.

Treatment:

Biological: EHSG-KF

Biological: STSG