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    Clinical Trial Results:
    A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural Repair

    Summary
    EudraCT number
    		 2009-016501-41
    Trial protocol
    		 DE   BE   NL   FI   GB  
    Global end of trial date
    25 Oct 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Aug 2016
    First version publication date
    05 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    400-09-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01174992
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ethicon Inc., a Johnson & Johnson Co.
    Sponsor organisation address
    Route 22 West , Somerville, United States,
    Public contact
    Jonathan Batiller, Ethicon Inc., a Johnson & Johnson Co., 001 9082182492, JBatill2@its.jnj.com
    Scientific contact
    Jonathan Batiller, Ethicon Inc., a Johnson & Johnson Co., 001 9082182492, JBatill2@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Dec 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Oct 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the safety and efficacy of Evicel for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.
    Protection of trial subjects
    The protocol and consent form were provided to the appropriate Ethics Committee for approval.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    United Kingdom: 48
    Country: Number of subjects enrolled
    Belgium: 43
    Country: Number of subjects enrolled
    Finland: 7
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Australia: 3
    Worldwide total number of subjects
    139
    EEA total number of subjects
    136
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    104
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first subject was consented on the 30 June 2010 and the last subject completed 25-Oct-2011.

    Pre-assignment
    Screening details
    		 Prospective subjects were screened within 21 days prior to surgery. Prior to any study related procedures, subjects were fully informed of all aspects of the study and asked to sign a consent form.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EVICEL
    Arm description
    		 EVICEL is a human plasma-derived fibrin sealant, consisting of two components: Biological Active Component 2 (BAC2), comprising human fibrinogen, and a stabilized solution of Human Thrombin, which incorporates Calcium.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EVICEL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sealant
    Routes of administration
    Topical use
    Dosage and administration details
    For each subject, one kit of EVICEL (2ml each of BAC2 and Thrombin [total 4ml]) was pre-prepared in the applicator kit prior to randomization. EVICEL was to be applied to the surgical site by either spraying or dripping onto the dural suture line.

    Arm title
    		 Sutures
    Arm description
    		 Sutures
    Arm type
    		 Sutures

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		EVICEL Sutures
    Started
    89
    50
    Completed
    79
    47
    Not completed
    10
    3
         Consent withdrawn by subject
    -
    1
         Pt refused to complete visit
    3
    1
         No 30 day visit scheduled
    2
    -
         Start of radiation therapy
    1
    -
         Lost to follow-up
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EVICEL
    Reporting group description
    		 EVICEL is a human plasma-derived fibrin sealant, consisting of two components: Biological Active Component 2 (BAC2), comprising human fibrinogen, and a stabilized solution of Human Thrombin, which incorporates Calcium.

    Reporting group title
    Sutures
    Reporting group description
    		 Sutures

    Reporting group values
    		 EVICEL Sutures Total
    Number of subjects
    		 89 50 139
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 56 (20 to 78) 59.5 (29 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 45 27 72
        Male
    		 44 23 67
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis set

    Subject analysis sets values
    		 FAS
    Number of subjects
    139
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    56 (20 to 78)
    Gender categorical
    Units: Subjects
        Female
    72
        Male
    67

    End points

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    End points reporting groups
    Reporting group title
    EVICEL
    Reporting group description
    		 EVICEL is a human plasma-derived fibrin sealant, consisting of two components: Biological Active Component 2 (BAC2), comprising human fibrinogen, and a stabilized solution of Human Thrombin, which incorporates Calcium.

    Reporting group title
    Sutures
    Reporting group description
    		 Sutures

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis set

    Primary: Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage defined as no CSF leakage from dural repair intraoperatively, during Valsalva maneuver 20-25cm H20 for 5-10 seconds

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    End point title
    		 Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage defined as no CSF leakage from dural repair intraoperatively, during Valsalva maneuver 20-25cm H20 for 5-10 seconds
    End point description
    Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage defined as no CSF leakage from dural repair intraoperatively, during Valsalva maneuver 20-25cm H20 for 5-10 seconds
    End point type
    Primary
    End point timeframe
    Intraoperative
    End point values
    		 EVICEL Sutures
    Number of subjects analysed
    89
    50
    Units: Number of successes
    82
    19
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    Sutures v EVICEL
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - P value of < 0.001 was also found during analysis using Fisher's exact test

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE's were collected from the start of randomization, throughout the hospital admission and until completion of the 30 day follow up visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    EVICEL
    Reporting group description
    		 EVICEL is a human plasma-derived fibrin sealant, consisting of two components: Biological Active Component 2 (BAC2), comprising human fibrinogen, and a stabilized solution of Human Thrombin, which incorporates Calcium.

    Reporting group title
    Sutures
    Reporting group description
    		 Sutures

    Serious adverse events
    		 EVICEL Sutures
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 89 (11.24%)
    4 / 50 (8.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastasis
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal fluid rhinorrhoea
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial palsy
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural hygroma
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Meningitis
         subjects affected / exposed
    1 / 89 (1.12%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EVICEL Sutures
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 89 (64.04%)
    31 / 50 (62.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    12 / 89 (13.48%)
    8 / 50 (16.00%)
         occurrences all number
    13
    8
    Hypotension
         subjects affected / exposed
    6 / 89 (6.74%)
    1 / 50 (2.00%)
         occurrences all number
    6
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 89 (19.10%)
    6 / 50 (12.00%)
         occurrences all number
    20
    6
    General disorders and administration site conditions
    Swelling
         subjects affected / exposed
    4 / 89 (4.49%)
    5 / 50 (10.00%)
         occurrences all number
    5
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 89 (10.11%)
    3 / 50 (6.00%)
         occurrences all number
    10
    3
    Vomiting
         subjects affected / exposed
    9 / 89 (10.11%)
    1 / 50 (2.00%)
         occurrences all number
    10
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    4 / 89 (4.49%)
    4 / 50 (8.00%)
         occurrences all number
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Mar 2010
    A number of updates were made to clarify: Pressure to be used for the Valsalva maneuver Exclusion of pediatric patients Use of non-autologous tissue based patches
    01 Oct 2010
    A number of updates to clarify: Use of Fibrin sealant as a rescue treatment The use of adjunct for durability of closure for the control group Various inclusion/exclusion criteria It also covered increasing the number of sites.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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.

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