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    Clinical Trial Results:
    Wound Management in Post-Bariatric Surgery Investigation for the reduction of the mean drainage volume in patients after abdominoplasty / lower body lift using Artiss Fibrin Sealant in comparison to the standard procedure

    Summary
    EudraCT number
    		 2013-004353-24
    Trial protocol
    		 DE  
    Global end of trial date
    03 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2020
    First version publication date
    09 Aug 2020
    Other versions
    Summary report(s)
    		 Synopsis WMPS

    Trial information

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    Trial identification
    Sponsor protocol code
    WMPS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS: DRKS00011036
    Sponsors
    Sponsor organisation name
    Universität Leipzig
    Sponsor organisation address
    Ritterstr. 26, Leipzig, Germany, 04109
    Public contact
    IFB Adipositas Data Center, Universität Leipzig, ZKS Leipzig, christiane.prettin@zks.uni-leipzig.de
    Scientific contact
    IFB Adipositas Data Center, Universität Leipzig, ZKS Leipzig, christiane.prettin@zks.uni-leipzig.de
    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
    03 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The aim of the trial is to assess the effectiveness of the Artiss™ fibrin sealant compared to the standard technique in reducing the volume of wound drainage fluid in patients that have undergone a planned post-bariatric body contouring operation. The primary endpoint in the volume of wound drainage fluid.
    Protection of trial subjects
    Patients observed closely for AE and SAE
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Aug 2014
    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
    Germany: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    16
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 There was no screening period.

    Period 1
    Period 1 title
    overall Trial (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
    		 Artiss fibrin sealant
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Artiss
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sealant
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    91 mg/ml milligram(s)/millilitre

    Arm title
    		 Standard of Care
    Arm description
    		 -
    Arm type
    		 standard of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Artiss fibrin sealant Standard of Care
    Started
    8
    10
    Completed
    8
    10

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Artiss fibrin sealant
    Reporting group description
    		 -

    Reporting group title
    Standard of Care
    Reporting group description
    		 -

    Primary: efficacy of artiss

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    End point title
    		 efficacy of artiss [1]
    End point description
    draining volume during hospitalisation
    End point type
    Primary
    End point timeframe
    periprocedural
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: For statistical analysis please see the attached trial synopsis.
    End point values
    		 Artiss fibrin sealant Standard of Care
    Number of subjects analysed
    8
    10
    Units: whole
    8
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    from surgery to end of study
    Adverse event reporting additional description
    not recorded
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    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: For details regarding (S)AEs please see the attached trial synopsis.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Aug 2015
    - change of PI and deputys - extension of recruitment period - specification of procedure of drainage

    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
    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.

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