E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adults and adolescents with partial deep dermal and full thickness burns |
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E.1.1.1 | Medical condition in easily understood language |
Adults and adolescents with partial deep dermal and full thickness burns |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy and safety of EHSG-KF in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns. Primary 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
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E.2.2 | Secondary objectives of the trial |
First Secondary Objective: • % Epithelialization at 3 months post grafting
Secondary Objectives: 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 ColorMeter® 3, 6, 12, 24 and 36 months post grafting o POSAS-questionnaire 3, 6, 12, 24 and 36 months post grafting • Graft take at 6-10 days post grafting • % Epithelialization at 3 and 4 weeks, and 2 and 6 months post grafting • Incidence of wound closure at 4, 8 and 12 weeks post grafting • Growth (% change in surface area, cm2, between 1 and 3 years post grafting) • Assessment and reporting of all observed adverse events • QOL assessment • Healthcare resource utilization (direct and indirect healthcare costs, this questionnaire will not be handed out to patients) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age: ≥12 years of age • Deep partial thickness and/or full thickness burns requiring surgical wound coverage
• Expected that ≥90cm2 of wound 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. |
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E.4 | Principal 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 • Patients with a known history of malignancy • 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 with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen • 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) • Suspicion of non-accidental injury • 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
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) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
First Secondary 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. • Other secondary efficacy endpoint: Epithelialization at visit 6 (28 +/-3 days post grafting) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Gold standard treatment of burns |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 8 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 30 |