Adults with partial deep dermal and full thickness burns.
Conditions
Interventions
Product Name: EHSG-KF
Product Code: EHSG-KF
Pharmaceutical Form: Cutaneous patch
INN or Proposed INN: Autologous Skin Cells
CAS Number: na
Current Sponsor code: na
Other descriptive name: Human Skin C
Sponsors
University of Zurich, Tissue Biology Research Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age: =18 years of age ? Deep partial thickness and/or full-thickness burns requiring surgical wound coverage ? The following two criteria must be met: - Expected that =90cm2 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, - >25% TBSA burn ? Signed Informed consent from the patient or the legally authorized representative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
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 meshed STSG based on: ? Ratio of covered surface area to biopsy site/donor site surface area 4 weeks post grafting ;Secondary Objective: To evaluate the safety and efficacy of EHSG-KF in comparison to meshed STSG based on the assessment of: ? Infection ? Scar quality: o Cutometer® 3, 6, 12, 24 and 36 months post grafting o DSM II ColorMeter® 3, 6, 12, 24 and 36 months post grafting o POSAS-questionnaire 3, 6, 12, 24 and 36 months post grafting ? %Epithelialization at 4 weeks post grafting ? Graft take at 4-11 days post grafting ? %Epithelialization at each study visit (to estimate ‘time to complete epithelialization’) ? Incidence of wound closure at 8 and 12 weeks post grafting ? Assessment and reporting of all adverse events (expected and unexpected) ? QOL assessment (EQ-5D and BSHS-B) ? Healthcare resource utilization (direct healthcare costs, this questionnaire will not be handed out to patients);Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: o visit 6 (28 +/-3 days post grafting) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 o visits 4 (4-11 days post grafting) o visit 5 (21 +/-2 days post grafting) ? 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) ? Other secondary safety endpoint: 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: Epithelialization at: o visit 6 (28 +/-3 days post grafting) Exploratory Endpoints ? Graft take of the study areas assessed in a standardized manner as percentage of the whole grafted area during the first dressing change at: o visit 4 (4-11 days post grafting) ? % 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 (28 +/-3 days post grafting) ? Incidence of wound closure at: o visit 7 (60 +/-3 days post grafting) o visit 8 (90 +/-5 days post grafting) ? Assessment of elasticity of the study areas using the Cutometer® at: o visit 8 (90 +/-5 days post grafting) o visit 9 (6 months +/-10 days post grafting) o visit 11 (2 years +/-30 days post grafting) o visit 12 (3 years +/-30 days post grafting) ? Assessment of general scar quality at the study areas using the POSAS, a reliable and validated scar assessment tool, at: o visits 8 (90 +/-5 days post grafting) o visit 9 (6 months +/-10 days post | — |
Countries
Italy, Netherlands, Switzerland
Contacts
Public ContactClinical Trial Manager
University of Zurich
Outcome results
None listed