Grote huiddefecten Skin abnormality skin condition
Conditions
Interventions
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: Grafting of th
Sponsors
CUTISS AG
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age: >=1 year of age •Large full-thickness defects that require coverage after excision of: -Scars -Benign skin tumors (e.g. neurofibroma) -Melanocytic nevus (e.g. giant nevus) - Gender reassignment surgery -Soft tissue defect after trauma -Soft tissue defect after infection and debridement (e.g. necrotizing fascitis, hidradentitis suppurativa, purpura fulminans) -Flap donor site (e.g. radial forearm flap) •Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): -Minimum: 1-5 years: 9 cm2 - Minimum: 6-16 years: 25 cm2 -Minimum: > 16 years: 45 cm2 •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 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints Efficacy evaluation, as a comparison between the EHSG-KF and control sites, based on: - 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) 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, color, pliability, thickness, relief) and total score at visit 8 (90 days +/-5 days after grafting) o DSM ColorMeter® (erythema and pigmentation) at: visit 10 (1 year +/-30 days post grafting) o 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) Secondary safety endpoints: - Clinical and microbiologic signs of infection at o visits 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. 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 a burn scar o EQ-5D only for patients >=18 years without burn scars o EQ-5DY and PedsQLpatients | — |
Countries
Netherlands
Outcome results
None listed