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    EudraCT Number:2005-003662-41
    Sponsor's Protocol Code Number:MW2004-11-02
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-10-20
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-003662-41
    A.3Full title of the trial
    Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care
    Sbrigliamento enzimatico nei pazienti ustionati (adulti e minori): Confronto con il trattamento standard
    A.4.1Sponsor's protocol code numberMW2004-11-02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMEDIWOUND
    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.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 NA
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDebrase Gel Dressing
    D.3.9.1CAS number 37189-34-7
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D. medicinal product typemistura di enzimi proteolitici liofilizzati derivati dal fusto dell'ananas
    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
    Adult and children patients with burn wounds defined as deep partial thickness or full thickness thermal burns requiring hospitalization.
    Pazienti adulti e minori con ustioni termiche a spessore profondo parziale o completo che richiedono ospedalizzazione.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10022117
    E.1.2Term Injury, poisoning and procedural complications
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 debridement 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).
    Obiettivo di questo studio e' valutare la sicurezza e l'efficacia di sbrigliamento enzimatico del Debrase Gel Dressing (DGD) in pazienti ospedalizzati con ustioni termiche a spessore profondo parziale o completo su 5-30% della superficie corporea totale (TBSA), ma con una estensione complessiva delle ustioni non superiore al 30% della TBSA e confrontare il DGD al trattamento standard (SOC).
    E.2.2Secondary objectives of the trial
    not specified
    non specificati
    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 &#8805; 5% and &#8804; 30% Total Body Surface Area (TBSA); all these wounds must receive study treatment, 4. At least one wound of &#8805; 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 &#8804; 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.
    1. Maschi e femmine con un'eta' compresa tra i 4 ed i 55 anni 2. Ustioni termiche causate da fuoco/fiamme, liquidi caldi/vapore o contatto 3. Ustioni termiche a spessore profondo parziale (dermiche miste profonde) e/o a spessore completo (3°) su una superficie &#61619;5% e &#61603; 30% della superficie corporea totale (TBSA); tutte queste ustioni devono ricevere il trattamento in studio 4. Almeno una ustione a spessore profondo parziale e/o a spessore completo con estensione &#61619; 2% della TBSA 5. Almeno il 50% dell'area dell'ustione a spessore profondo parziale e/o a spessore completo del paziente candidata allo sbrigliamento chirurgico al momento del ricovero 6. Ustioni termiche su una area complessiva &#61603; al 30% della TBSA 7. Ricovero ospedaliero entro 24 ore dal momento in cui si e' verificata l'ustione. I pazienti trasferiti da un altro ospedale/clinica possono essere arruolati se il primo ricovero si e' verificato entro le 24 ore dall'insorgenza dell'ustione e l'ammissione al centro ustioni che partecipa allo studio si verifica entro 48 ore dall'insorgenza dell'ustione. 8. Firma del consenso informato scritto.
    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 anrolled but the wounds may not be deisgnated as target wounds), 4. Circumferential anterior/posterior trunk full thickness fire/flame burns, > 15% TBSA, (Circumferential is defined as encircling &#8805; 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 &#8805; 20.0 x 103 cells/µL; Children aged 4-16: WBC &#8805; 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 attempts, 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.
    1. Presenza di altri gravi traumi cutanei nello stesso sito dell'ustione (ovvero traumi da oggetti smussati, avulsione o abrasione profonda) o precedente/i ustione/i nello/negli stesso/i sito/i che richiede/richiedono il trattamento o una o piu` ustioni termiche che non rispondono ai criteri di studio 2. Ustioni al viso a spessore parziale profondo e/o a spessore completo &gt; 0.5% TBSA; il trattamento di studio delle ustioni al viso non e` permesso 3. Trattamento di studio di ustioni perineali e/o genitali (Un paziente con queste ustioni puo` essere arruolato, ma tali ustioni non possono essere considerate come ustioni target) 4. Ustioni circumferenziali da fuoco/fiamma antero/posteriori del busto a completo spessore &gt; 15% TBSA (Circumferenziale significa che abbraccia &#61619; 80% della circonferenza del busto) 5. A. Medicazione pre arruolamento come riportato: a. Flammacerium, b. Nitrato d'Argento (AgNO3) B. Ustioni che, in fase di pre arruolamento, sono state coperte da escara pesantemente saturata di iodio o da pseudo-escara (es. pseudo-escara risultante da un trattamento con sulfadiazina d'argento). 6. Escarotomia antecedente l'arruolamento 7. Ustioni fortemente contaminate o infezioni pre-esistenti (Negli adulti: GBC &#61619;20.0 x 103 unita`/&#61549;L; minori con eta` compresa tra 4 e 16 anni: GBC &#61619;25.0 x 103 unita`/&#61549;L) 8. Segni che possano indicare inalazione di fumo 9. Condizioni generali del paziente secondo le quali la chirurgia e` controindicata 10. Prigionieri 11. Donne in stato di gravidanza (positive al test di gravidanza) o donne in allattamento 12. Diabete mellito scarsamente controllato (HbA1c &gt; 9%) 13. Presenza di patologia cardio-polmonare (infarto del miocardio nelle 4 settimane antecedenti la lesione, ipertensione polmonare, malattia polmonare cronica ostruttiva o pre-esistenti patologie polmonari ossigeno dipendente) 14. Concomitanza di pre-esistenti patologie che interferiscono con la circolazione (patologia vascolare periferica, edema, linfoedema, intervento chirurgico ai linfonodi regionali, obesita`, vene varicose) 15. Presenza di condizioni che minacciano nel breve la vita del paziente (quali patologie che compromettono il sistema immunitario, trauma con pericolo di vita, grave patologia della coagulazione pre-esistente, patologia cardiovascolare, epatica o neoplastica) 16. Assunzione cronica di steroidi per via sistemica 17. Storia di allergia e/o nota sensibilita` all'ananas o alla papaina 18. Recenti tentativi di suicidio 19. Partecipazione ad un altro studio con farmaco sperimentale 20. Attuale abuso di alcol o droghe 21. Assunzione di analgesici che impediscono al paziente di comprendere gli obiettivi, la natura e lo svolgimento dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    The two co-primary endpoints are % treated wound excised (by tangential/minor/Versajet excision) or dermabraded, in first surgery, and % 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 both these analyses. The secondary end points are treated wound excised (by tangential/minor/Versajet excision) or dermabraded, in first surgery, for all wounds; time to complete wound closure; timely eschar removal (debridement)and blood loss.
    I due endopoints co-primari sono costituiti dalla % di ustioni trattate con escissione (escissione tangenziale/minore/con Versajet) o dermoabrasione come chirurgia primaria e, delle lesioni a spessore parziale profondo, la percentuale di lesione trattata autoinnestata dove e` possibile vedere il potenziale effetto sul risparmio tissutale. Le ustioni che sono interamente a spessore completo o hanno aree a spessore completo sono escluse da entrambe le analisi. Gli end-points secondari sono costituiti dalla ustione trattata escissa (mediante escissione tangenziale/minore/con Versajet) o dermoabrasa, in prima chirurgia per tutte le ustioni; il tempo per la completa chiusura della lesione, la rimozione tempestiva dell`escara (sbrigliamento) e la perdita ematica.
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 Yes
    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. description
    confronto con il trattamento standard
    E.8.2.4Number of treatment arms in the trial2
    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 EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 0
    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 2008-10-20. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F. of other specific vulnerable populations
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    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 Decision2008-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-01-29
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