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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-000232-15
    Sponsor's Protocol Code Number:HIDROGEL-014
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-07-15
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-000232-15
    A.3Full title of the trial
    Analgesic efficacy of levobupivacaine administered by wet wound dressing for the management split-thickness skin graft donor sites
    Eficacia analgésica de la levobupivacaína administrada mediante apósitos de cura en ambiente húmedo sobre zonas donantes de injertos de piel parcial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Analgesic efficacy of levobupivacaine administered by wet wound dressing on skin graft donor site
    Eficacia analgésica de la levobupivacaína administrada mediante apósitos en lan
    zonas donantes del injerto de piel.
    A.3.2Name or abbreviated title of the trial where available
    HIDROGEL-014
    HIDROGEL-014
    A.4.1Sponsor's protocol code numberHIDROGEL-014
    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 SponsorConsorcio Hospital General Universitario de Valencia . Servicio de Anestesia , Reanimacion y tto del Dolor
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportConsorcio Hospital General Universitario de Valencia . Servicio de Anestesia , Reanimacion y tto del Dolor
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConsorcio Hospital General Universitario de Valencia .
    B.5.2Functional name of contact pointServ de Anestesia, Reanimacion
    B.5.3 Address:
    B.5.3.1Street AddressAvda Tres Cruces, 2
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46014
    B.5.3.4CountrySpain
    B.5.4Telephone number+34617322858
    B.5.5Fax number+34961972303
    B.5.6E-mailmolinervelazquez@gmail.com
    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 Yes
    D.2.1.1.1Trade name CHIROCANE 7,5 mg/ml SOLUCION INYECTABLE
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE FARMACEUTICA, S.L.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOBUPIVACAINE
    D.3.9.1CAS number 27262-47-1
    D.3.9.2Current sponsor codechirocane
    D.3.9.3Other descriptive namelevobupivacaine
    D.3.9.4EV Substance CodeSUB08464MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number7.5 to 150
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute postoperative pain
    Dolor agudo postoperatorio
    E.1.1.1Medical condition in easily understood language
    postoperative pain
    dolor tras intervencion quirurgica
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    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
    evaluate the analgesic efficacy of L-Bupivacaine 0.75% (max 20 ml) vs.placebo (saline) administered by wet wound dressing for the management split-thickness skin graft donor sites
    Probar la eficacia analgésica de hasta 20 ml de volumen de L-Bupivacaina 0,75% vs placebo (suero fisiológico), administrados topicamente con el
    apósito de cura en ambiente húmedo en la zona donante del injerto.
    E.2.2Secondary objectives of the trial
    1 . Assess pain intensity at 24h by VAS. 2. Set the difference in analgesic requirements of intravenous tramadol consumption, as rescue medication, in each of the groups at 24 hours after the end of anesthesia. 3. Assess pain intensity at 72h by VAS. 4. the time until reepithelialization (up to 15 days).
    1. Intensidad del dolor en la zona donante, medida con la escala de valoración del dolor EVA a las 24 horas en el postoperatorio inmediato. 2. Establecer la diferencia entre grupos en la necesidad de analgésicos utilizando para su valoración: el consumo de tramadol intravenoso en mg administrada en forma de rescate a todos los pacientes. Se evaluará a las 24 horas en el postoperatorio inmediato. 3. Intensidad del dolor en la zona donante, medida con la escala de valoración del dolor EVA a las 72 horas en el postoperatorio inmediato. 4. Tiempo transcurrido hasta la reepitelización completa de la herida quirúrgica de la zona donante (hasta 15 dias tras la intervención)
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Intensidad del dolor en la zona donante, medida con la escala de valoración del dolor EVA a las 24 horas en el postoperatorio inmediato.
    2. Establecer la diferencia entre grupos en la necesidad de analgésicos utilizando para su valoración: el consumo de tramadol intravenoso en
    mg administrada en forma de rescate a todos los pacientes. Se evaluará a las 24 horas en el postoperatorio inmediato.
    3. Intensidad del dolor en la zona donante, medida con la escala de valoración del dolor EVA a las 72 horas en el postoperatorio inmediato.
    4. Tiempo transcurrido hasta la reepitelización completa de la herida quirúrgica de la zona donante (hasta 15 dias tras la intervención)
    E.3Principal inclusion criteria
    1. Patients> 18 and <= 75 years. 2. Patients had an split-thickness skin graft donor site area of 50?150 cm2. 3. Skin graft donor site anterior or
    posterior thigh. 4. Hospitalization of at least 72 hours. 5. Informed consent signed
    1. Pacientes mayores de 18 años y menores o igual a 75 años.2.Pacientes con defectos cutáneos susceptibles de ser cubiertos por injerto de piel parcial de superficie entre 50 y 150 cm2. 3.Zona donante en la cara anterior o posterior del muslo. 4. Ingreso hospitalario previsto de al menos 72 horas tras la cirugía. 5. Firma del consentimiento informado.
    E.4Principal exclusion criteria
    1. Rejection of the patient 2. Surgical procedure superior than 6hrs.3.Other conditions that warrant their inclusion as medically indicated: severe kidney illness (grade 3-4). severe hepatic illness (ChildPugh B and C grades), psychiatric illness), arrythmias, coagulation disorders, preganacy o lactation.
    4. Allergy to NSAIDs, local anesthetics and / or opioids. 5. Alcoholism. 6. Abuse drugs. 7. ASA III or higher 8. When the surgery procedure time is 1 hour
    more from the moment of obtention of the graft
    1. Rechazo de la paciente. 2 Tiempo quirúrgico mayor de 6h de duración 3 Otras enfermedades que aconsejen su no inclusión según criterio médico: patología severa renal (estadio 3 y 4), patología hepática (ChildPugh estadios B y C) o psiquiatrica, trastornos del ritmo cardiaco, trastornos de la coagulación, el embarazo y la lactancia.4. Alergia a AINES, anestésicos locales y/o a mórficos. 5 Alcoholismo. 6. Adicción a drogas. 7. Estado funcional ASA>3 8. Intervención quirúrgica que se prolongue mas de 1 hora tras obtener la pieza del injerto.
    E.5 End points
    E.5.1Primary end point(s)
    Patient-reported postoperative pain, evaluated by a Visual Analog Scale (VAS)
    La intensidad del dolor medido con la escala de valoración del dolor EVA
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 hours from wet wound dressing is placed over donor site.
    A las 6 horas de la colocación del apósito de cura.
    E.5.2Secondary end point(s)
    Efficacy: 1.Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS). 2. Intravenous Tramadol used (mg).
    3. the time until reepithelialization of donor site.
    Safety: 1. Adverse events and unwanted systemic and locally side effects that the patient relate and observed by investigators. 2. Other explorations carried out occasionally or symptoms that the patient relate.
    Eficacia: 1.La intensidad del dolor medido con la escala de valoración del dolor EVA . 2. Consumo de tramadol intravenoso en mg . 3. Tiempo hasta la reepitelización de la zona donante. Seguridad: 1. Acontecimientos adversos, reacciones adversas locales y generales, comunicadas por el paciente y observadas por el personal sanitario. 2. Otras exploraciones que ocasionalmente se realicen o síntomas que el paciente relate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: 1. At 24 and 72 hours from wet wound dressing is placed over donor site, in point number 1. 2. At 24 hours, in point number 2. 3. From 7th to 15th days (every 72 hours), after surgery, in point number 3.
    Safety: Every study visits.
    Eficacia: 1. A 24 y 72 horas de la colocación del apósito húmedo en la zona donante, en el punto nº1. 2. A las 24 horas, en el punto nº2. 3. Desde el día 7 hasta como máximo 15 días tras la cirugía (cada 72 horas) , en el punto nº3. Seguridad: En todas las visitas del estudio.
    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 Yes
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS iis the last visit of the last subject enter.
    El Final del Estudio es la última visita del último paciente incluido.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NONE
    ninguno
    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 Decision2016-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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