ernstige brandwonden dermal burns skin damage due to heat
Conditions
Interventions
Product:
EHSG-KF is an autologous tissue-engineered dermo-epidermal skin substitute on
a collagen type I hydrogel. The size per graft is 45±4cm2 and the thickness is
0.5-2 mm.
Intervention:
Graf
Sponsors
CUTISS AG
Eligibility
Age
No minimum to 11 Years
Inclusion criteria
Inclusion criteria: • Age: =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 from the patient or the parents/legally authorized representative.
Exclusion criteria
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 • Pre-existing coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| First secondary efficacy endpoint: • % Epithelialization at: o visit 8 (90 ± 5 days post grafting) Secondary Endpoints Safety and efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on: • Main secondary safety endpoint: Clinical and microbiologic signs of infection at visits 4 (6-10 days post grafting) and 5 (21 +/-2 days post grafting) • Main secondary efficacy endpoints: Scar quality at the study areas 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) • 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 • Other secondary efficacy endpoint: Epithelialization at visit 6 (28 +/-3 days post grafting) | — |
Countries
Netherlands
Outcome results
None listed