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    Summary
    EudraCT Number:2017-000152-26
    Sponsor's Protocol Code Number:IOW-1755-REI-0540-I
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-04-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-000152-26
    A.3Full title of the trial
    Intraoperative wound irrigation to prevent surgical site infection after
    laparotomy
    Intraoperative Wundspülung zur Prävention von postoperativen
    Wundinfektionen nach Laparatomie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intraoperative wound irrigation to prevent surgical site infection after
    laparotomy
    Intraoperative Wundspülung zur Prävention von postoperativen
    Wundinfektionen nach Laparatomie
    A.3.2Name or abbreviated title of the trial where available
    IOWSI
    A.4.1Sponsor's protocol code numberIOW-1755-REI-0540-I
    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 SponsorTechnische Universitaet Muenchen School for Medicine
    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 supportDeutsche Forschungsgesellschaft (DFG) grant number: MU 3928/1-1
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTechnische Universität München Klinikum rechts der Isar
    B.5.2Functional name of contact pointKlinik und Poliklinik für Chirurgie
    B.5.3 Address:
    B.5.3.1Street AddressIsmaningerstr. 22
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number0049(0)8941405019
    B.5.5Fax number0049(0)8941406322
    B.5.6E-maildaniel.reim@tum.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.2.5The 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 Irrigation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOLIHEXANIDE
    D.3.9.1CAS number 32289-58-0
    D.3.9.4EV Substance CodeSUB09970MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 placeboIrrigation solution
    D.8.4Route of administration of the placeboOther use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    To investigate whether the use of intraoperative, epifascial wound
    irrigation with polyhexanide (PHX) solution can reduce surgical site
    infections after laparotomy for visceral surgery compared to saline
    irrigation or no irrigation.
    Untersuchung ob die intraoperative epifasziale Wundspülung des
    Subkutangewebes mit Polyhexanid (PHX) Lösung im Vergleich zu
    Wundspülung mit Kochsalzlösung oder keiner Wundspülung, die Rate an postoperativen Wundinfektionen nach abdominal chirurgischen
    Eingriffen mittels Laparotomie vermindern kann.
    E.1.1.1Medical condition in easily understood language
    Wound irrigation for the prevention of postoperative wound infections.
    Wundspülung zur Vorbeugung von postoperativen Wundinfekten.
    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
    To investigate whether the use of intraoperative, epifascial wound irrigation with polyhexanide (PHX) solution can reduce surgical site infections after laparotomy for visceral surgery compared to saline irrigation or no irrigation.
    Untersuchung ob die intraoperative epifasziale Wundspülung des Subkutangewebes mit Polyhexanid (PHX) Lösung im Vergleich zu Wundspülung mit Kochsalzlösung oder keiner Wundspülung, die Rate an postoperativen Wundinfektionen nach abdominal chirurgischen Eingriffen mittels Laparotomie vermindern kann.
    E.2.2Secondary objectives of the trial
    not applicable
    nicht zutreffend
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Clean-contaminated, contaminated or dirty surgery according to Centre for Disease Control (CDC) classification;
    • Abdominal surgery by midline or transverse laparotomy; elective and emergency procedures;
    • Age ≥ 18 years;
    • American Society of Anesthesiologists (ASA) score ≤ 3;
    • Ability to understand the nature and extent of the trial and to give written informed consent;
    • Sauber-kontaminierte, kontaminierte oder septische, abdominal-chirurgische Eingriffe laut Center for Disease Control (CDC)-Klassifikation
    • Abdominal-chirurgische Eingriffe mittels Längs- oder Querlaparotomie, sowohl elektiv als auch notfallmäßig;
    • Alter ≥ 18 Jahre;
    • ASA (American Society of Anesthesiologists) Score ≤ 3;
    • Fähigkeit die Patientenaufklärung zu verstehen und zu unterschreiben;
    E.4Principal exclusion criteria
    • Pregnancy or breast feeding;
    • Known hypersensitivity/allergy to PHX;
    • Inability to understand/give informed consent;
    • ASA >3;
    • Inability to attend follow-up visits;
    • Clean procedures according to the CDC classification or surgery without opening of the abdominal cavity;
    • Laparoscopic surgery;
    • Revision-surgery (previous abdominal surgery within the last 30 days);
    • Planned re-laparotomy within 30 days;
    • Severe immunosuppression;
    • Concurrent abdominal wall infections;
    • Pre-operative antibiotic therapy (within 5 days prior to surgery) except for emergencies due to septic peritonitis
    • Schwangerschaft oder Stillzeit;
    • Bekannte Überempfindlichkeit / Allergie auf PHX;
    • Unfähigkeit den Studieninhalt zu verstehen oder einzuwilligen;
    • ASA >3;
    • Unfähigkeit die Studienvisiten wahrzunehmen;
    • Saubere Eingriffe analog CDC-Klassifikation, ohne Eröffnung der Abdominalhöhle
    • Laparoskopische Eingriffe
    • Revisionseingriffe (vorheriger Eingriff innerhalb der letzten 30 Tage)
    • Geplante Re-Laparotomie innerhalb von 30 Tagen
    • Schwere Immunsuppression
    • Simultane Bauchwand Infektionen
    • Prä-operative antibiotische Therapie innerhalb von 5 Tagen vor dem geplanten Eingriff (mit Ausnahme der Notfalltherapie bei septischer Peritonitis)
    E.5 End points
    E.5.1Primary end point(s)
    SSI according to CDC criteria within 30 days postoperatively
    Rate an postoperativen Wundinfektionen innerhalb von 30 Tagen analog der CDC-Definition
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    30 Tage
    E.5.2Secondary end point(s)
    • Non-infectious wound complications (e.g. seroma, hematoma, delayed healing) within 30 days
    • Duration of hospital stay
    • Mortality within 30 days postoperatively
    • Incidence of reoperation within 30 days
    • Incidence of AE/SAE within 30 days
    • Nicht-infektiöse Wundkomplikationen (z.B. Serom, Hämatom, verzögerte Wundheilung) innerhalb 30 Tage postoperativ
    • Dauer des stationären Krankenhausaufenthaltes
    • Mortalität innerhalb von 30 Tagen postoperativ
    • Re-Operationsrate innerhalb von 30 Tagen postoperativ
    • AE/SAE Inzidenzrate unnerhalb 30 Tage postoperativ
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days
    30 Tage
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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.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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    3 Gruppen
    3 groups
    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.8.3 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 concerned10
    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
    11/2019 LVLS
    11/2019 letzte Visite letzter Patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state540
    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 end of the study patients regardless of whether the study end
    according to the protocol or early / non-terminated according to
    protocol, the patient get continued Treatment by Physician or clinic standard therapie.
    Nach Ende der Studie können Patienten unabhängig davon, ob die
    Studie protokollgemäß oder vorzeitig/nicht-protokollgemäß beendet
    wurde, bekommen die Patienten eine Weiterbehandlung beim Hausarzt oder die Standard Therapie der jeweiligen Klinik in der der Patient liegt.
    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 Decision2017-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-27
    P. End of Trial
    P.End of Trial StatusOngoing
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