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    Clinical Trial Results:
    Use of TachoSil® for the prevention of postoperative complications after groin dissection in vulva cancer patients

    Summary
    EudraCT number
    		 2016-001191-30
    Trial protocol
    		 DK  
    Global end of trial date
    09 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2024
    First version publication date
    16 Dec 2024
    Other versions
    Summary report(s)
    		 Abstract: USE OF TACHOSIL® FOR THE PREVENTION OF POSTOPERATIVE COMPLICATIONS AFTER GROIN DISSECTION IN VULVA CANCER PATIENTS

    Trial information

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    Trial identification
    Sponsor protocol code
    IISR-2015-101127
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Copenhagen University Hospital
    Sponsor organisation address
    Blegdamsvej 9, Rigshospitalet, Denmark, 2100
    Public contact
    Ligita Paskeviciute Frøding, Department of Obstetrics & Gynecology, Copenhagen University Hospital, Rigshospitalet, Denmark, 0045 35459719, ligitapask@dadlnet.dk
    Scientific contact
    Ligita Paskeviciute Frøding, Department of Obstetrics & Gynecology, Copenhagen University Hospital, Rigshospitalet, Denmark , 0045 35459719, ligitapask@dadlnet.dk
    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
    02 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate and compare the incidence of symptomatic lymphocele (defined by CTCAE 4.03 grade ≥2) within 4 weeks after surgery in women undergoing ILND for vulva cancer with or without the application of TachoSil® during surgery
    Protection of trial subjects
    Non
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 74
    Worldwide total number of subjects
    74
    EEA total number of subjects
    74
    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)
    26
    From 65 to 84 years
    46
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with vulva cancer and inguinal lymphadenectomy were recrouted in to gynecologic oncology departments at Copenhagen University Hospital and Aarhus University Hospital

    Pre-assignment
    Screening details
    		 101 patients were screened for the inclusion. 74 patients were included and 27 were excluded due to exclusion criteria.

    Period 1
    Period 1 title
    Intervention (Overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 Patiens after inguinafemoral lymphadenectomy who were applied Tachosil prior standard wound closure
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tachosil
    Investigational medicinal product code
    Other name
    Tachosil
    Pharmaceutical forms
    Sealant
    Routes of administration
    Use in body cavities
    Dosage and administration details
    One patch per inguen

    Arm title
    		 Control
    Arm description
    		 Patients after inguinofemoral lymphadenectomy, standard closure
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Intervention Control
    Started
    39
    35
    Completed
    39
    35

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Patiens after inguinafemoral lymphadenectomy who were applied Tachosil prior standard wound closure

    Reporting group title
    Control
    Reporting group description
    		 Patients after inguinofemoral lymphadenectomy, standard closure

    Reporting group values
    		 Intervention Control Total
    Number of subjects
    		 39 35 74
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 13 13 26
        From 65-84 years
    		 26 22 48
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 39 35 74

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Patiens after inguinafemoral lymphadenectomy who were applied Tachosil prior standard wound closure

    Reporting group title
    Control
    Reporting group description
    		 Patients after inguinofemoral lymphadenectomy, standard closure

    Primary: The primary outcome is the incidence of symptomatic lymphocele (defined by CTCAE 4.03 grade ≥2) within 4 weeks after surgery in women undergoing IL for vulva cancer with or without the application of TachoSil® during surgery.

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    End point title
    		 The primary outcome is the incidence of symptomatic lymphocele (defined by CTCAE 4.03 grade ≥2) within 4 weeks after surgery in women undergoing IL for vulva cancer with or without the application of TachoSil® during surgery.
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks after surgery
    End point values
    		 Intervention Control
    Number of subjects analysed
    39
    35
    Units: 1-4
    number (not applicable)
        Incidens of lymphocele
    18
    11
    Statistical analysis title
    		 Descriptive statistics
    Comparison groups
    Control v Intervention
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.24
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During one year post-surgery. Wound complications after groin dissection (lymphocele (6-40%), wound breakdown (13-39%) and cellulitis (14-57%)) are common surgical complications after lymphnode dissection in groins and were not considered as AEs or ARs.
    Adverse event reporting additional description
    The clinical assesment was used. Events were considered to be possibly related to the TachoSil® if they occured in the time interval from the time of application of the patches and up to 24 hours after application. Adverse reactions occurring more than 24 hours after application were not be registered.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Events were considered to be possibly related to the TachoSil® if they occured in the time interval from the time of application of the patches and up to 24 hours after application. Adverse reactions occurring more than 24 hours after application were not registered. Wound complications after groin dissection (lymphocele (6-40%), wound breakdown (13-39%) and cellulitis (14-57%)) are common surgical complications after lymphnode dissection in groins and were not considered as AEs or ARs.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    02 Mar 2020
    COVID-19 pandemic
    -

    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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