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    Summary
    EudraCT Number:2012-005653-22
    Sponsor's Protocol Code Number:NL13PAR
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-05-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-005653-22
    A.3Full title of the trial
    TachoSil patch application as replacement of closed suction wound drainage by parotid gland surgery; a prospective study.
    TachoSil applicatie als vervanging van wonddrainage bij parotischirurgie; een prospectieve studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Surgical sealant application as replacement of a wound drain by parotid gland surgery; a prospective study.
    Toepassing van een chirurgische afdichtingsspons als vervanging van een wonddrain bij parotischirurgie; een prospectieve studie.
    A.3.2Name or abbreviated title of the trial where available
    TachoSil parotidectomy
    TachoSil parotidectomie
    A.4.1Sponsor's protocol code numberNL13PAR
    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 SponsorNetherlands Cancer Institute-Antoni van Leeuwenhoek Hospital
    B.1.3.4CountryNetherlands
    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 supportNetherlands Cancer Institute-Antoni van Leeuwenhoek
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNetherlands Cancer Institute-Antoni van Leeuwenhoek Hospital
    B.5.2Functional name of contact pointA.J.M. Balm
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310205122550
    B.Sponsor: 2
    B.1.1Name of SponsorTakeda Nederland B.V.
    B.1.3.4CountryNetherlands
    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 supportTakeda Nederland B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNetherlands Cancer Institute-Antoni van Leeuwenhoek Hospital
    B.5.2Functional name of contact pointA.J.M. Balm
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310205122550
    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 TachoSil
    D.2.1.1.2Name of the Marketing Authorisation holderNycomed Austria GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTachoSil
    D.3.4Pharmaceutical form Medicated sponge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The surgical procedure of parotidectomy whereby a protid tumor is
    removed. During this procedure the wound surface will be covered by
    the surgical sealing patch TachoSil instead of the use of a closed suction
    drain.
    De chirurgische parotidectomie procedure waarbij een parotistumor
    wordt verwijderd. Tijdens deze procedure zal in plaats van een
    wonddrain het wondgebied wordt bedekt met TachoSil.
    E.1.1.1Medical condition in easily understood language
    The surgical removal of (a part of the) parotid gland in case of a parotid
    tumor, whereby the surgical wound will be covered by a surgical sealing
    patch.
    De chirurgische verwijdering van (een deel van) de parotisklier in verband met een tumor, waarbij in plaats van een
    wonddrain het wondgebied wordt bedekt met een chirurgische
    afdichtingsspons.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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 primary objective of the study is to provide evidence that the use of
    a sealing surgical patch applied to the surgical field following
    parotidectomy is non-inferior (according to preset limits) to the common
    practice of CSD insertion by wound closure, measured by post-operative
    wound complications (haematoma, haemorrhage, wound infection,
    seroma, dehiscence, skin necrosis).
    If so, TachoSil will be able to replace CSD because it is much more
    convenient for patients than a CSD. It means no irritation of the drain,
    no potential infection route and no need for specialized care in the
    hospital so more early discharge and resulting in recovery in the own
    home environment.
    Het primaire doel van deze studie is het aantonen dat het gebruik van
    een afdichtings spons op het operatieve wondgebied bij een
    parotidectomie niet-inferieur is (op basis van vooraf opgestelde
    grenzen) ten opzichte van de huidige standaard van het achterlaten van
    een wonddrain, gemeten in het post-operatieve percentage
    wondcomplicaties (hematoom, nabloeding, wond infectie, seroom,
    dehiscentie en huidnecrose).
    Als dit bewijs kan worden geleverd zal TachoSil de wonddrain kunnen
    vervangen omdat het veel patiënt vriendelijker is dan een drain; er is
    geen irritatie van de drain, geen potentiële route voor infectie en geen noodzaak voor specialistische zorg zodat patiënten sneller naar huis
    kunnen en in hun eigen omgeving kunnen herstellen.
    E.2.2Secondary objectives of the trial
    Secondary parameters include facial nerve function and more tardy
    complications like fistula, sialocele and Frey's syndrome. Additionally,
    patient satisfaction (measured by short questionnaire), duration of hospital
    admission and the need for re-admission will be recorded.
    Secundaire parameters bevatten de functie van de aangezichtszenuw en
    de latere complicaties als fistels, sialoceles en syndroom van Frey.
    Additioneel zullen ook patiënt tevredenheid (gescoord met een korte
    vragenlijst), duur van de ziekenhuisopname en de eventuele noodzaak
    tot heropname worden geregistreerd.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients undergoing surgery for a parotid gland tumor.
    • Indications for parotidectomy are
    - fine needle aspiration cytology (FNAC) proven benign or malignant
    parotid tumors
    - Persistent clinical suspicion of a parotid tumor despite negative FNAC.
    • For this prospective study patients undergoing all forms of parotid
    surgery are eligible.
    • Patients with benign as well as malignant parotid tumors are eligible,
    even when the latter is a metastasis from another malignant primary
    tumor.
    • There is no age limit.
    • Signed informed consent is required.
    Patiënten die een operatie ondergaan voor een parotis tumor.
    • Indicaties voor parotidectomie zijn
    - een door fijne naald aspiratie cytologie (FNAC) bewezen benigne of
    maligne parotis tumor of
    - een persisterende klinische verdenking op een parotis tumor ondanks
    negatieve FNAC.
    • Voor deze prospectieve studie zijn patiënten geschikt die iedere vorm
    van parotis chirurgie ondergaan.
    • Zowel benigne als maligne tumoren geschikt zijn voor inclusie, zelfs
    als de laatste een metastase is van een andere primaire maligne tumor.
    • Er is geen leeftijds limiet.
    • Getekende informed consent is vereist.
    E.4Principal exclusion criteria
    Patients meeting (one of) the following criteria are excluded from
    participation in this study:
    • Pre-existing coagulation disorders (anticoagulant therapy must be on
    pause, continuing use of acetylsalicylic acid is permitted)
    • History of surgery, radiation or open trauma to the ipsilateral neck or
    parotid area
    • Receiving concurrent neck dissection because of the extent of the
    surgical field
    • Known allergy for the product of TachoSil or its substances like for
    human blood products or horse protein.
    • Anamnestic presence of pregnancy or nursery giving.
    Patiënten die voldoen aan (een van de) volgende criteria zijn uitgesloten van deelname aan de studie:
    • Reeds bestaande stollingsstoornissen (antistollings therapie moet
    gepauzeerd worden, doorgebruik thrombocytenaggregatie is
    toegestaan)
    • Voorgeschiedenis van chirurgie, bestraling of trauma aan de
    ipsilaterale hals of parotis regio.
    • Het ondergaan van gelijktijdige halsklier dissectie vanwege de
    uitbreiding van het operatieve wondbed.
    • Bekende allergie voor het product TachoSil of de bestanddelen zoals
    humane bloed producten of paarden proteïne.
    • Anamnestisch aanwezige zwangerschap of borstvoeding geven.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percent of patients who developed a wound complication after the intervention. Parotidectomy including additional application of the TachoSil patch instead of closed suction drainge is thought to result in a wound complication rate that is not inferior (according to preset limits) compared to the standard procedure of closed suction drainage without TachoSil.
    The number of wound complications will be recorded prospectively.
    De primaire uitkomstmaat is het percentage van de patiënten bij wie een wond complicatie optreedt na de interventie met TachoSil. De toepassing van TachoSil bij parotidectomie wordt verwacht te resulteren in een wondcomplicatie ratio die niet inferieur is (op basis van vooraf vastgestelde grenzen) vergeleken met de standaard procedure met wonddrain en zonder TachoSil. Het aantal wondcomplicaties zal prospectief genoteerd worden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the inclusion and follow-up of 112 consecutive patients, the results of these patients will be compared with the retrospective cohort of 400
    patient who are treated by parotidectomy the last 10 year.
    Na de inclusie en follow-up van 112 opeenvolgende patiënten zullen de
    resultaten van deze patienten worden vergeleken met de retrospectieve controlegroep van 400 patienten die de laatste 10 jaar een parotidectomie hebben ondergaan.
    E.5.2Secondary end point(s)
    Secondary endpoint include facial nerve function and more tardy complications like fistula, sialocele and Frey's syndrome. Additionally, patient satisfaction will be measured by short survey. These endpoints will only be discribed because of these parameters are not welldocumented in the retrospective cohort. However, duration of hospital admission and the need for re-admission will be recorded and tried to be compared to the retrospective cohort.
    Secundaire uitkomstmaten bevatten de functie van de aangezichtszenuw en de latere complicaties als fistels, sialoceles en syndroom van Frey. Additioneel zal ook patiënt tevredenheid gescoord worden met een korte vragenlijst. Deze uitkomstmaten zullen alleen beschreven worden aangezien deze parameters niet voldoende gedocumenteerd zijn in de retrospectieve groep.
    Echter, duur van de ziekenhuisopname en de eventuele noodzaak tot heropname zal wel worden geregistreerd en worden geprobeerd te vergelijken met de retrospectieve groep.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the inclusion and follow-up of 112 consecutive patients, the results of these patients - if possible - will be compared with the retrospective cohort of 400 patient who are treated by parotidectomy the last 10 year.
    Na de inclusie en follow-up van 112 opeenvolgende patiënten zullen de
    resultaten van deze patienten - indien mogelijk - worden vergeleken met de retrospectieve controlegroep van 400 patienten die de laatste 10 jaar een parotidectomie hebben ondergaan.
    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 No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    een-arm, niet gerandomiseerde prospectieve studie met een retrospectieve samengestelde controlegroep
    single-arm, non-randomized prospective study, with a retrospective assembled control group
    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
    retrospectieve samengestelde controlegroep van 400 met vacuumdrainage behandelde patienten
    retrospective assembled control group of 400 patients treated by closed suction drainage
    E.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    After 112 patients are treated and seen in follow-up, sufficient information is thought to be collected to perform an analysis regarding TachoSils safety and efficacy compared to the retrospective cohort. If any kind of problem dictates further medical investigation, this will postpone the last visit.
    Nadat 112 patiënten zijn behandeld en vervolgd gedurende de followup, is voldoende informatie verzameld om de analyse te verrichten met betrekking tot de veiligheid en effectiviteit van TachoSil vergeleken met de retrospectieve controlegroep. Als enig ander probleem verder medisch onderzoek vereist, dan zal het laatste bezoek worden uitgesteld.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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: 112
    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 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 state112
    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)
    There are no treatment plans different than the current standard of
    care, that each patient treated with a parotidectomy will receive.
    Er zijn geen behandelingsplannen anders dan de huidige standaard behandeling, die iedere patient die behandeld is met een parotidectomie ontvangt.
    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 Decision2014-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-25
    P. End of Trial
    P.End of Trial StatusOngoing
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