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    Summary
    EudraCT Number:2015-001309-14
    Sponsor's Protocol Code Number:MINDED
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-09
    Trial results View 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 ConcernedGermany - PEI
    A.2EudraCT number2015-001309-14
    A.3Full title of the trial
    Comparison of the efficacy of using a human acellular dermis (Epiflex®) against the surgical standard procedure for closing an open abdomen with respect to avoiding ventral hernia.
    A monocenter, partly-blind, controlled, prospective and randomised phase-III clinical trial.
    Vergleich der Wirksamkeit einer humanen azellulären Dermis (Epiflex®) gegen ein chirurgisches Standardtherapieverfahren im Verschluss des offenen Abdomens in Bezug auf die Vermeidung der ventralen Hernienentwicklung.
    Eine monozentrische, teil-verblindete, kontrollierte, prospektive und randomisierte klinische Phase III Studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the usage of a human acellular dermis instead of applying the surgical standard procedure for closing an open abdomen.
    Beurteilung der Verwendung einer humanen azellulären Dermis (Epiflex®) anstatt des chirurgischen Standardtherapieverfahrens beim Verschluss eines offenen Abdomens.
    A.3.2Name or abbreviated title of the trial where available
    MINDED (Mannheim opeNabDomEn acellular Dermis)
    A.4.1Sponsor's protocol code numberMINDED
    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 SponsorUniversity of Heidelberg
    B.1.3.4CountryGermany
    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 supportDeutsches Institut für Zell- und Gewebeersatz GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Mannheim
    B.5.2Functional name of contact pointMINDED Project Management Office
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Kutzer Ufer 1-3
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68167
    B.5.3.4CountryGermany
    B.5.4Telephone number00496213833433
    B.5.5Fax number00496213831479
    B.5.6E-mailstudien@gisg.de
    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 Epiflex®
    D.2.1.1.2Name of the Marketing Authorisation holderDeutsches Institut für Zell- und Gewebeersatz GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameEpiflex®
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeAcellular human dermis
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Ethicon Vicryl™
    D.2.1.1.2Name of the Marketing Authorisation holderEthicon
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameEthicon Vicryl™
    D.3.4Pharmaceutical form Implantation matrix
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    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 Yes
    D.3.11.13.1Other medicinal product typeAbsorbable, synthetic vicryl net to be implanted
    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
    open abdomen
    offenes Abdomen
    E.1.1.1Medical condition in easily understood language
    open abdomen
    offenes Abdomen
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000082
    E.1.2Term Abdominal pain generalised
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000085
    E.1.2Term Abdominal pain NOS
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10000092
    E.1.2Term Abdominal scan NOS abnormal
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000095
    E.1.2Term Abdominal symptom NOS
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10000096
    E.1.2Term Abdominal syndrome acute
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000039
    E.1.2Term Abd. pain
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000040
    E.1.2Term Abdo pain
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to avoid ventral hernie building by applying Epiflex® for closure of the open abdomen instead of the standard technique (Ethicon Vicryl™)
    Vermeidung der Bildung einer ventralen Hernie durch den Einsatz von Epiflex® zum Verschluss des offenen Abdomens anstatt des Standardverfahrens (Ethicon Vicryl™)
    E.2.2Secondary objectives of the trial
    to improve the patient's quality of life due to the avoidance of ventral hernia building in patients having been subjected to implantation of the Epiflex® instead of the standard technique (Ethicon Vicryl™)
    Verbesserung der Lebensqualität des Patienten als Folge des Ausbleibens der Bildung einer ventralen Hernie bei Einsatz des Epiflex® anstatt des Standardverfahrens (Ethicon Vicryl™)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. open abdomen patients in the context of a severe peritonitis with the underlying focus being cured
    2. it should anatomically and from the surgical point of view be possible toprovid a cutaneous cover of the Epiflex®, minor rests could be treated by NPW therapy (VAC therapy)
    3. patients themselves of in the case of a patient not capable of giving consent his/her legal representative must provide written informed consent prior the performance of study-specific procedures and must be willing to comply with the intervention and follow-up examinations of the study
    4. patients aged ≥ 18 years
    5. treatment of peritonitis must be completed (necessity for re-laparotomy caused by the Epiflex®/Lavage should be very unlikely)
    6. patients must comply to not become pregnant within the time span of 24 weeks after Implantation of the Epiflex®/Ethicon Vicryl™
    7. adequate knowledge of the german language to understand the patient Information and implement the planned study procedures according to the protocol
    1. Patienten zur „offenem Abdomen“ Behandlung im Rahmen einer schweren Peritonitis deren ursächlicher Fokus saniert ist.
    2. Anatomisch und operationstechnisch sollte das einzulegende Epiflex® weitgehend kutan zu decken sein; kleine Rest-Defekte können mit NPW-Therapie (VAC-Therapie) zu versorgen sein)
    3. unterschriebene Einverständniserklärung des Patienten/der Patientin bzw. des gerichtlich bestellten Betreuers für seine Heilfürsorge bei nicht einwilligungsfähigen Patienten/Patientinnen vor Studieneinschluss
    4. Patientenalter ≥ 18 Jahre..
    5. mutmaßlich abgeschlossene Peritonitisbehandlung (eine weitere Notwendigkeit für eine Re-laparotomie durch das Epiflex®/Lavage muss höchst unwahrscheinlich sein)
    6. Teilnehmerinnen müssen bereit sein in der Nachbeobachtungsphase von 24 Wochen nach Netzimplantation (Epiflex®/Ethicon Vicryl™) nicht schwanger zu werden.
    7. Ausreichende Kenntnisse der deutschen Sprache zur Aufklärung und Durchführung der einzelnen Bestandteile des Studienablaufs
    E.4Principal exclusion criteria
    1. patients with gastrointestinal leakage in upper GI tract or proximal jejunum
    2. patients with leakage or fistula within hepatobiliar or pancreatic system
    3. patients with fluoring pancreatitis
    4. patients with uncontrolled intraabdominal malignant disease
    5. patients with open abdomen that have not been able to get mobilized (ECOG 4) or are expected not be able to be mobilized until 12 weeks after surgical study invention (ECOG 4)
    6. patients bearing a pace maker
    7. patients under dialysis treatment
    8. patients whose abdominal walls hiscerence extends the largest available piece of (Epiflex®/Ethicon Vicryl™)
    9. patients with a life expectancy under 12 months
    10. patients under immunosuppression (for example those having underwent organ transplantation)
    11. patients under treatment of angiogenic inhibitors
    12. patients with existing diseases of the hematopoietic system
    13. patients being pregnant and planning pregnancy within 24 weeks +/- 14 days after surgical implantation of the Epiflex®/ Ethicon Vicryl™
    14. patients not capable of giving consent and with no legal representative at the same time

    1. Patienten mit gastrointestinale Leckage im oberen GI Trakt oder proximalen Jejunum
    2. Patienten mit Leckage oder Fistel im hepatobiliären oder pankreatischen System
    3. Patienten mit Florider Pankreatitis
    4. Patienten mit nicht-kontrollierter intraabdominale maligne Erkrankungen
    5. Patienten, die vor der zugrundeliegenden Ursache des offenen Abdomens nicht mobilisierbar waren (ECOG 4) oder absehbar nach Rekonvalszenz innerhalb von 12 Wochen nach Studieneinschluss nicht mobilisierbar sein werden (ECOG 4)
    6. Patienten mit Herzschrittmacher
    7. Patienten unter Dialyse
    8. Patienten mit einer Bauchdeckendehiszenz größer als das größte verfügbare Stück hAD
    9. Patienten mit einer Lebenserwartung < 12 Monate
    10. Patienten mit bestehende medikamentöser Immunosuppression (z.B: bei Organ-Transplantierten)
    11. Patienten unter bestehender Therapie mit Angiogenese-Inhibitoren
    12. Patienten mit vorbestehender Erkrankungen des hämatopoetischen Systems
    13. Schwangerschaft (Ausschluss der Schwangerschaft in der Beobachtungszeit von 24 Wochen +/- 14 Tagen nach Netzimplantation)
    14. Nicht-einwilligungsfähige Patienten ohne Betreuer
    E.5 End points
    E.5.1Primary end point(s)
    to avoid ventral hernie building by applying Epiflex® for the closure of an open abdomen instead of the standard technique (Ethicon Vicryl™)
    Vermeidung der Bildung einer ventralen Hernie durch den Einsatz von Epiflex® zum Verschluss des offenen Abdomens anstatt des Standardverfahrens (Ethicon Vicryl™)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after surgical implantation of Epiflex®/Ethicon Vicryl™
    6 Monate nach chirurgischem Einsetzen des Epiflex®/Ethicon Vicryl™
    E.5.2Secondary end point(s)
    to improve the patient's quality of life due to the avoidance of ventral hernia building in patients having been subjected to implantation of the Epiflex® instead of the standard technique (Ethicon Vicryl™)
    Verbesserung der Lebensqualität des Patienten als Folge eines Ausbleibens der Bildung einer ventralen Hernie bei Einsatz des Epiflex® anstatt des Standardverfahrens (Ethicon Vicryl™)
    E.5.2.1Timepoint(s) of evaluation of this end point
    life quality questionaires (EuraHS- QoL und SF-36) to determine the patient's quality of life will be filled in by each patient 1-2 days prior to release fom hospital, 12 weeks +/- 7 days, 24 weeks +/- 14 days and 12 months +/- 14 days after surgical Implantation of the Epiflex®/Ethicon Vicryl™, respectively.
    Fragebogen zur Erhebung der Lebensqualität (EuraHS- QoL und SF-36) werden jeweils vom Patienten selbst ausgefüllt 1-2 Tage vor der Entlassung aus der Klinik, 12 Wochen +/- 7 Tage, 24 Wochen +/+ 14 Tage und 12 Monate +/- 14 Tage postoperativ
    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 No
    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) 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 No
    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 Yes
    E.8.1.7.1Other trial design description
    teilverblindet (offen in bezug auf Operateur, verblindet ggü. Patient und Prüfärzte)
    partly-blind (open-label to surgical MD, blind towards patient and to all follow-up trial MDs)
    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
    Ethicon Vicryl™, verwendet im Standardverfahren
    Ethicon Vicryl™, used in standard procedure
    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 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
    LVLS
    LVLS
    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 months48
    E.8.9.1In the Member State concerned days0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The severe medical situation of an open abdomen might include patients not capable of giving consent personally.
    Die medizinische Situation eines offenen Abdomens ist eine solche, die von der Schwere der Umstände Patienten einschließen kann, die nicht einwilligungsfähig sind.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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)
    After the trail has ended, no specific CT related care is necessary and planned.
    Nach Studienende ist keine weitere studienspezifische Nachsorge notwendig und geplant.
    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 Decision2016-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-02
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