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    Summary
    EudraCT Number:2005-003662-41
    Sponsor's Protocol Code Number:MW-2004-11-02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-09-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2005-003662-41
    A.3Full title of the trial
    Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)
    A.4.1Sponsor's protocol code numberMW-2004-11-02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMediWound Ltd
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/02/107
    D.3 Description of the IMP
    D.3.1Product nameDebrase Gel Dressing
    D.3.2Product code Debrase Gel Dressing
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeDebrase Powder
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeDebrase Powder
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Burn wounds defined as deep partial thickness or full thickness thermal burns.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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).
    E.2.2Secondary 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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    Two co-primary endpoints are:

    (1)The % treated wound excised (by tangential/minor/Versajet excision) or dermabraded, in first surgery. Wounds which are entirely full thickness or have full thickness areas are excluded from this analysis.

    Surgical excision/dermabrasion performed in first surgery 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. Wounds which are entirely full thickness or have full thickness areas are excluded from this analysis.
    (Footnote: Full thickness wounds require grafting due to lack of dermal remnants. The decision to graft combination wounds is often influenced by the presence of the full thickness component. Therefore, in order to show the clinical benefit of the tissue sparing effect of DGD, a homogenous wound population of deep partial thickness wounds will be included in this analysis.)

    The sum of all post-debridement autografts performed will be taken.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of Care - Surgical & Non surgical debridement
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial 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
    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.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-09-14. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children and adolescents
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 270
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-29
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