Adults and children with full thickness skin defects.
Conditions
Sponsors
University of Zurich, Tissue Biology Research Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age: =1 year of age ? 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 donorsite (e.g. radial forearm flap) ? Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): o Minimum: 1-5 y: 9 cm2 o Minimum: 6-16 years: 25 cm2 o Minimum: > 16 years: 45 cm2 ? Signed Informed consent from the patient or the legally authorized representative. Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 2
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 <LLN prior to the current hospital admission and / or at the Investigator’s discretion ? Patients allergic to amphotericin B and gentamicin ? 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 expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders) ? Pregnant or breast feeding females ? Intention to become pregnant during the clinical course of the study (12 months) ? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of EHSG-KF in comparison to STSG based on the assessment of: ? Scar quality: o POSAS questionnaire, observer total score 3 months post grafting;Secondary Objective: To evaluate the safety and efficacy of EHSG-KF in comparison to meshed STSG based on the assessment of: ? Scar quality: o Cutometer® 3 months post grafting o POSAS questionnaire, observer items 3 months post grafting o POSAS questionnaire, patient items and total score 3 months post grafting o DSM II ColorMeter® 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 post grafting) for histological assessment. (optional) ? Infection 4-11 days and 21 +/- 2 days post grafting ? Graft take at 4-11 days post grafting ? % Epithelialization at 28 days +/- 3 days post grafting ? Adverse events ? QOL assessment at visit 10 (1 year +/-30 days) after grafting o EQ-5D and BSHS-B for adults with reconstruction of burn scars, o EQ-5D only for all other adults, o EQ-5DY and PedsQL for all children i.e. patients who haven’t reached their 18th birthday on the day of screening;Primary end point(s): 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);Timepoint(s) of evaluation of this end point: o visit 8 (90 +/-5 days post grafting) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 II 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 (4-11 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 (4-11 days post grafting) o visit 5 (21 +/-2 days post grafting) ? Adverse events o Assessment and reporting of all adverse events (expected and unexpected) will be carried out for the full duration of the study Other secondary efficacy endpoint: ? QOL assessment: visit 10 (1 year +/-30 days post grafting) o EQ-5D and BSHS-B for adults with reconstruction of a burn scar o EQ-5D only for patients without burn scars o EQ-5DY and PedsQL for children (patients who haven’t reached their 18th birthday on screening day) Exploratory Endpoints ? % Epithelialization (to estimate time to complete epithelialization) at: o visit 5 (21 +/-2 days post grafting) o visit 7 (60 +/-3 days post grafting) o visit 8 (90 +/-5 days post grafting) o visit 9 (6months +/-10 days post grafting) ? Clinical and microbiologic signs of infection at: o visit 6 | — |
Countries
Italy, Netherlands, Switzerland
Contacts
Public ContactClinical Trial Manager
University of Zurich
Outcome results
None listed