BILAYER ENGINEERED COLLAGEN HYDROGEL-BASED SKIN GRAFT COMPOSED OF AUTOLOGOUS KERATINOCYTES AND FIBROBLASTS for Full-thickness skin defects

Inclusion criteria

• {"criterion_text":"- Age: ≥1 year of age\n- Large full-thickness defects that require coverage after excision of: o Scars o Benign skin tumors (e.g. neurofibroma) o Melanocytic nevus (e.g. giant nevus) o Gender reassignment surgery o Soft tissue defect after trauma o Soft tissue defect after infection and debridement (e.g. necrotizing fascitis, hidradentitis suppurativa, purpura fulminans) o Flap donor site (e.g. radial forearm flap)\n- Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): o Minimum: 1-5 years: 9 cm2 o Minimum: 6-16 years: 25 cm2 o Minimum: > 16 years: 45 cm2\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- Intention to become pregnant during the clinical course of the study (12 months)\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 prior to the current hospital admission and / or at the Investigator’s discretion\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 assessment of general scar quality at the study areas using the POSAS questionnaire, observer total score at: visit 8 (90 days ± 5 days post grafting)","definition_or_measurement_approach":"Assessment of general scar quality at study areas using the POSAS questionnaire, observer total score measured at visit 8 (90 days ± 5 days post grafting)."}

Secondary endpoints

• {"endpoint_text":"- Efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on (1): • Scar quality at the study areas in comparison to control areas: o Cutometer® pliability parameter at visit 8 (90 days ± 5 days post grafting) as key secondary efficacy endpoint o Other Cutometer® parameters (extension, elasticity, retraction, viscoelasticity) at visit 8 (90 days ± 5 days post grafting)","definition_or_measurement_approach":"Cutometer® measurements of pliability (key secondary) and additional parameters (extension, elasticity, retraction, viscoelasticity) at visit 8 (90 days ±5 days post grafting) comparing EHSG-KF and control sites."}
• {"endpoint_text":"- Based on (2): • Scar quality at the study areas in comparison to control areas: o POSAS questionnaire observer items (vascularity, pigmentation, thickness, relief, pliability) at visit 8 (90 days ± 5 days post grafting) o POSAS questionnaire patient items (pain, itching, colour, pliability, thickness, relief) and total score at visit 8 (90 days ± 5 days after grafting)","definition_or_measurement_approach":"POSAS observer items (vascularity, pigmentation, thickness, relief, pliability) and POSAS patient items (pain, itching, colour, pliability, thickness, relief) and total score at visit 8 (90 days ±5 days post grafting) comparing EHSG-KF and control."}
• {"endpoint_text":"- Based on (3): • Scar quality at the study areas in comparison to control areas: DSM ColorMeter® (erythema and pigmentation) at: visit 10 (1 year ± 30 days post grafting) o Optional biopsies of the study area and control area at visit 10 (1 year ± 30 days after grafting) for histological assessment. (optional) o Graft take at Visit 4 (6-10 days after grafting) o % Epithelialization at Visit 6 (28 days ± 3 days after grafting)","definition_or_measurement_approach":"DSM ColorMeter® measures (erythema and pigmentation) at visit 10 (1 year ±30 days); optional histological biopsies at visit 10; graft take assessed at Visit 4 (6-10 days post grafting); percent epithelialization at Visit 6 (28 days ±3 days)."}
• {"endpoint_text":"- Secondary safety endpoints: • Clinical and microbiologic signs of infection at o visit 4 (6-10 days post grafting) o visit 5 (21 ± 2 days post grafting) • Adverse events o 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":"Clinical and microbiologic infection signs assessed at visit 4 (6-10 days) and visit 5 (21 ±2 days); adverse events collected and assessed from visit 2 for full study duration."}
• {"endpoint_text":"- Other secondary efficacy endpoint: • QOL assessment: visit 10 (1 year ± 30 days post grafting) o EQ-5D and BSHS-B for patients ≥18 years with reconstruction of burn scars o EQ-5D only for patients ≥18 years without burn scars o EQ-5DY and PedsQL for patients <18 years","definition_or_measurement_approach":"Quality of life instruments at visit 10 (1 year ±30 days): EQ-5D and BSHS-B for ≥18 with burn-scar reconstruction; EQ-5D only for ≥18 without burn scars; EQ-5DY and PedsQL for <18 years."}

Italy

Earliest CTIS Part Ii Submission Date

24-10-2024

Latest Decision Or Authorization Date

04-11-2024

Processing Time Days

11

Number Of Sites

3

Number Of Participants

5

Netherlands

Earliest CTIS Part Ii Submission Date

24-10-2024

Latest Decision Or Authorization Date

28-10-2024

Processing Time Days

4

Number Of Sites

2

Number Of Participants

10

Primary sponsor

Full Name

Cutiss AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland