E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Burn wounds defined as deep partial thickness or full thickness thermal burns. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to evaluate the safety and enzymatic debriding efficacy of Debrase Gel Dressing (DGD) in hospitalized patients with deep partial thickness and full thickness thermal burns of 5-30% TBSA, but with total burn wounds of no more than 30% TBSA and to compare DGD to standard of care (SOC). |
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E.2.2 | Secondary objectives of the trial |
The purpose of this study is to identify the patient population that can best benefit from this new debriding agent and to provide evidence to confirm the clinical benefits of this agent. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Males and females between 4 years to 55 years of age, 2. Thermal burns caused by fire/flame, scalds or contact, 3. Deep partial thickness (mixed deep dermal) and/or full thickness (3°) burn wounds > or = 5% and < or = 30% Total Body Surface Area (TBSA); all these wounds must receive study treatment, 4. At least one wound of > or = 2% TBSA deep partial thickness and/or full thickness burn, 5. At least 50% of the deep partial thickness and/or full thickness burn wound area of the patient is intended for surgical debridement as judged at hospital admission, 6. Total burn wounds < or = 30% TBSA, 7. Hospital admission within 24 hours of the burn injury. Patients transferred from another hospital/clinic may be enrolled if the primary admission was within 24 hours of the burn injury and admission to the burn unit participating in the study was within 48 hours of the burn injury, 8. Signed written informed consent. |
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E.4 | Principal exclusion criteria |
1. Other severe cutaneous trauma at the same sites as the burns (i.e. blunt, avulsion or deep abrasion) or previous burn(s) at the same treatment site(s) or one or more burn wounds that do not meet study criteria, 2. Deep partial thickness and/or full thickness facial burn wounds, > 0.5% TBSA; study treatment of facial burns is not allowed, 3. Study treatment of perineal and/or genital burns (A patient with these wounds may be enrolled but the wounds may not be designated as target wounds.), 4. Circumferential anterior/posterior trunk full thickness fire/flame burns, > 15% TBSA, (Circumferential is defined as encircling > or = 80% of the trunk circumference.) 5. A. The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3), B. Pre-enrollment wounds which are covered by eschar heavily saturated with iodine or by pseudoeschar (e.g. pseudoeschar as a result of SSD treatment), 6. Pre-enrollment escharotomy, 7. Heavily contaminated burns or pre-existing infections (Adults: WBC > or = 20.0 x 103 cells/μL; Children aged 4-16: WBC > or = 25.0 x 103 cells/μL), 8. Signs that may indicate smoke inhalation, 9. General condition of patient would contraindicate surgery, 10. Prisoners, 11. Pregnant women (positive pregnancy test) or nursing mothers, 12. Poorly controlled diabetes mellitus (HbA1c>9%), 13. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases), 14. Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins), 15. Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease), 16. Chronic systemic steroid intake, 17. History of allergy and/or known sensitivity to pineapples or papain, 18. Current suicide attempt 19. Participation in another investigational drug trial, 20. Current alcohol or drug abuse. 21. Analgesic intake which prevents the patient from understanding the objectives, nature and course of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Two co-primary endpoints are: (1) The % treated wound excised (by tangential/minor/Versajet excision) or dermabraded, in first surgery. First surgical excision/dermabrasion is defined as tangential/minor/Versajet excision or dermabrasion, performed (a) as the initial eschar removal (debridement) procedure in the surgical SOC group, or (b) as the first surgical debridement performed after initial eschar removal (debridement), in the DGD or non-surgical debridement (NSD) SOC groups.
(2) The % treated wound autografted of deep partial wounds where the potential tissue-sparing effect may be seen. The first post-debridement autograft performed will be taken. Wounds which are entirely full thickness or have full thickness areas are excluded from this analysis. |
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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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
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 |
Standard of Care - Surgical & Non surgical debridement |
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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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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 | Information not present in EudraCT |
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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Each patient will be followed up weekly (Weeks 1, 2, 3 and 4 etc.) until wound closure for all his/her burns. Three monthly visits will be conducted, post-wound closure. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |