Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-000727-25
    Sponsor's Protocol Code Number:47582
    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:2017-03-28
    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 number2014-000727-25
    A.3Full title of the trial
    The effect of ARTISS on latissimus dorsi donor site seroma formation after breast reconstruction: a randomised controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of a fibrin sealant (ARTISS) to analyze the formation of serous fluid at the back, after harvesting a latissimus dorsi musle to reconstruct a breast.
    A.4.1Sponsor's protocol code number47582
    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 SponsorIsala Klinieken
    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 supportZWIK
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZWIK
    B.5.2Functional name of contact pointZwols Wetenschapsfonds Isala Klinie
    B.5.3 Address:
    B.5.3.1Street Addressdr. van Heesweg 2
    B.5.3.2Town/ cityZwolle
    B.5.3.3Post code10400
    B.5.3.4CountryNetherlands
    B.5.6E-mailzwik@isala.nl
    D. IMP Identification
    D.IMP: 1
    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 ARTISS
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameARTISS
    D.3.4Pharmaceutical form Suspension and solution for spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    Subcutaneous use
    Topical 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) Yes
    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 aim of this study is to investigate the effect of the fibrin sealant ARTISS compared with our standard care on total volume of donor site seroma after harvesting a LD in immediate breast reconstruction.
    Our secondary outcomes are drainage volume and duration of drainage, length of hospital stay of a patient, other postoperative complications besides donor site seroma (such as infection), pain measured by the Visual Analog Scale (VAS), and costs in euros.
    E.1.1.1Medical condition in easily understood language
    Seroma: wound fluid
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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 aim of this study is to investigate the effect of ARTISS compared with our standard care on total volume of donor site seroma after harvesting a LD in breast reconstruction.
    E.2.2Secondary objectives of the trial
    Our secondary outcomes are drainage volume and duration of drainage, length of hospital stay of a patient, other postoperative complications besides donor site seroma (such as infection), pain measured by the Visual Analog Scale (VAS), and costs in euros.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All female patients older than 18 years, who will undergo a breast reconstruction with a LD flap will be included. All participating patients have to sign a written consent, before they can be included in our study.
    E.4Principal exclusion criteria
    Patients who are pregnant, have a pre-operative on-going infection, history of systemic anti-coagulant use, known hypersensitivity to ARTISS or postoperative haemorrhage will be excluded.
    E.5 End points
    E.5.1Primary end point(s)
    The aim of this study is to investigate the effect of ARTISS compared with conventional care (i.e., only vacuum drains after wound closure) on the formation of total volume of donor site seroma after harvesting a LD for breast reconstruction. Seroma is diagnosed, when ≥ 20 mL can be aspirated after fine needle aspiration or diagnosed with ultrasound after removal of all drains.
    During hospitalization drainage volumes will be measured starting on day one. The drains will be removed if measured output is less than 50 mL per 24h. The duration of drainage will be recorded (i.e., in days). When the drains are removed and when the patient does not have fever, no drains, no severe pain (VAS score ≤ 4), no signs of an infection, and when the patient can manage daily activities, the patient can be discharged. Clinical examination will be performed at one, two, six, and twelve weeks after discharge. Evidently, when the patient reports discomfort caused by seroma in-between the standard moments afore-mentioned, he or she will visit the hospital and these visits will also be counted. Also the amount of punctation of seroma will be analysed. An aspiration of the seroma is neccesary when a patient reports discomfort caused by seroma or if the size of the seroma is ≥ 20mL, diagnosed with clinical examination and/ or by ultrasound seroma is aspirated. Otherwise, seroma-related complication can occur, such as infection or necrosis of the skin.
    In addition to the formation of seroma, other complications will be taken into account. That is, the total volume of drainage during hospitalization, duration of drainage, donor-site pain, length of stay in the hospital, and costs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During hospitalization drainage volumes will be measured starting on day one. The duration of drainage will be recorded (i.e., in days). When the drains are removed (<50cc/24h), the patient does not have fever or pain (VAS score ≤ 2), and no signs of an infection, the patient can be discharged. Clinical examination will be performed at one, two, six, and twelve weeks after discharge. Evidently, when the patient reports discomfort caused by seroma in-between the standard moments afore-mentioned, he or she will visit the hospital and these visits will also be counted. It will also be evaluated how many times the seroma has to be punctuated (when the patient reports discomfort caused by seroma or if the size of the seroma is ≥ 20mL, diagnosed with clinical examination and/ or by ultrasound).
    E.5.2Secondary end point(s)
    Secondary outcomes include total drainage volume, duration of drainage, pain, length of stay in the hospital, and costs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The same timepoints as afore-mentioned.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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.8.2.3.1Comparator description
    No other therapy, just standard therapy (= same therapy, only without application of Artiss)
    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
    In case of unexpected and critical side effects of ARTISS, this study will be terminated early. The principle investigator will inform all included patients about these side effects.
    Furthermore, if all data of all included patients are included, the study will end if all study parameters are conducted. Yearly the Isala Clinics performs 23 breast reconstruction with the LD flap. In total, 118 patients should be included (power analysis). So, 5 years are necessary to gain all data.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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: 118
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state118
    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)
    One group (ARTISS group) will undergo treatment with the combination of the fibrin sealant ARTISS and suction drains. Two suctions drains will be inserted in both groups. Postoperative treatment and discharge will be performed according to our hospital’s protocol and this is the same in both groups. Postoperative treatment and discharge criteria will be the same as in the intervention group. No extra treatment or care are planned after ending of our study.
    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 Decision2017-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 09:27:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA