Bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts for Deep partial-thickness burns | Full-thickness burns

Inclusion criteria

• {"criterion_text":"- Age: <12 years of age\n- Deep partial thickness and/or full-thickness burns requiring surgical wound coverage\n- 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.\n- Signed informed consent from the patient or the parents/legally authorized representative."}

Exclusion criteria

• {"criterion_text":"- Patients tested positive for HBV, HCV, syphilis or HIV\n- Suspicion of non-accidental injury\n- Wounds in the head and neck area as study target area (only applicable for study patients in The Netherlands)\n- Enrolment of the Investigator, his/her family members, employees, and other dependent persons\n- 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)\n- Severe drug and alcohol abuse\n- Pre-existing coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen \n- Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen\n- Previous enrolment of the patient into the current phase II study\n- Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study\n- Patients or parents/ legally authorized representative expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)\n- Pregnant or breast feeding females"}

Primary endpoints

• {"endpoint_text":"- Efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on: - Ratio of covered surface area to biopsy site/donor site surface area at: - visit 6 (28 ± 3 days post grafting)","definition_or_measurement_approach":"Primary measure: Ratio of covered surface area to biopsy site/donor site surface area assessed at visit 6 (28 ± 3 days post grafting), i.e. approximately 4 weeks post grafting."}

Secondary endpoints

• {"endpoint_text":"- % Epithelialization at: - visit 8 (90 ± 5 days post grafting)","definition_or_measurement_approach":"Percent epithelialization assessed at visit 8 (90 ± 5 days post grafting)."}
• {"endpoint_text":"- Safety and efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on: see point 3 - 6","definition_or_measurement_approach":"Composite evaluation referencing secondary endpoints 3-6 (infection, scar quality, graft take, epithelialization timepoints, wound closure incidence, growth, AEs, QOL, resource use)."}
• {"endpoint_text":"- Main secondary safety endpoint: Clinical and microbiologic signs of infection at: o visit 4 (6-10 days post grafting) o visit 5 (21 ± 2 days post grafting)","definition_or_measurement_approach":"Clinical examination and microbiologic assessment for signs of infection performed at visit 4 (6-10 days) and visit 5 (21 ± 2 days) post grafting."}
• {"endpoint_text":"- Main secondary efficacy endpoints: Scar quality at the study areas o Assessment of elasticity of the study areas using the Cutometer® at visit 10 (1 year ± 30 days post grafting) o Assessment of general scar quality at the study areas using the POSAS, a reliable and validated scar assessment tool, at visit 10 (1 year ± 30 days post grafting)","definition_or_measurement_approach":"Scar quality assessed by Cutometer (elasticity) and POSAS at visit 10 (1 year ± 30 days post grafting); additional scar assessments at multiple timepoints per protocol (3,6,12,24,36 months referenced in objectives)."}
• {"endpoint_text":"- Other secondary safety endpoint: Assessment and reporting of all observed adverse events will be carried out for the full duration of the study from visit 2 on.","definition_or_measurement_approach":"Continuous adverse event collection and reporting from visit 2 for the full study duration; standard AE/SAE reporting procedures per protocol."}
• {"endpoint_text":"- Other secondary efficacy endpoint: Epithelialization at: o visit 6 (28 ± 3 days post grafting)","definition_or_measurement_approach":"Percent epithelialization measured at visit 6 (28 ± 3 days post grafting) to assess early graft epithelialization/take."}

Netherlands

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

21-10-2024

Processing Time Days

39

Number Of Sites

1

Number Of Participants

4

Italy

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

28-10-2024

Processing Time Days

46

Number Of Sites

2

Number Of Participants

4

Primary sponsor

Full Name

Cutiss AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland