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Randomized Assessment of Devices Used to Prevent Post-operative Hemorrhagic Risk in Endonasal Surgery (PRHEPOCE)

Primary Purpose

Otorhinolaryngologic Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgiflo
Floseal
Algosteril
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Otorhinolaryngologic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • endonasal surgery schedule
  • Surgical indications:

hypertrophic rhinitis, repeated or chronic infections, extraction of foreign body, polyposes naso-sinusal, benign tumors limited to the nasal pit and in sine,

Exclusion Criteria:

  • Pregnant Woman
  • Disorder of the haemostasis known or disrupted preoperative biological balance assessment
  • Use of treatment disrupting the blood coagulation (anti platelet, anti vitamin K, AINS)
  • Unchecked HTA by the treatment and/or preoperative > mmHg 160/90
  • Surgical Act including a septoplasty
  • malignant tumoral surgical Indication, or mild overtaking the naso-sinusial system
  • Dacryocystorhinostomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Surgiflo

    Floseal

    Algosteril

    Abstention

    Arm Description

    Using Surgiflo® (Absorbable Gelatin Hemostatic) for the post-operative haemostasis in endonasal surgery.

    Using Floseal® (Absorbable Gelatin Hemostatic) containing human thrombin for the post-operative haemostasis in endonasal surgery

    Using Algosteril® (Hemostatic Sterile Wick) for the post-operative haemostasis in endonasal surgery

    Not using device for the post-operative haemostasis in endonasal surgery

    Outcomes

    Primary Outcome Measures

    Per-operative hemostasis
    Time needs to observe hemostasis after the device set up
    Hemostasis in the 6 first hours
    Number of compresses used from Hours 0 to Hours 6.
    Hemostasis at the 24th hour
    Algosteril arm (after having removed the wick): spontaneous observation of hemostasis in less that 3 min (yes/no) and needs to have a new intervention to stop bleedings (type) Surgiflo, Floseal, Abstention arms: time to observe hemostasis if bleedings occurred.
    Spontaneous hemorrhagic events
    number of spontaneous hemorrhagic events.

    Secondary Outcome Measures

    Preoperative assessment
    Preoperative scanner assessment with Lund ans Mackay score
    Preoperative assessment
    Laboratory tests of hemostasis (platelets, fibrinogen...)
    Device evaluation by the surgeon
    time needs to set up the device
    Device evaluation by the surgeon
    subjective assessment of the implementation ease

    Full Information

    First Posted
    August 2, 2017
    Last Updated
    August 4, 2017
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03243344
    Brief Title
    Randomized Assessment of Devices Used to Prevent Post-operative Hemorrhagic Risk in Endonasal Surgery
    Acronym
    PRHEPOCE
    Official Title
    Randomized Medico-economic Assessment of Preventive Devices Used for Post-operative Hemorrhagic Risk in Endonasal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates the efficiency and the cost of three medical devices and the abstention of the use of specific product for the post-operative haemostasis in endonasal surgery .
    Detailed Description
    Surgiflo® is a matrix of haemostatic frost of porcine protein origin is the coverage of the post-operative bleeding of which one of the indications is in endonasal surgery. Floseal® is a haemostatic frost(gel) containing of the thrombin. Algosteril® is a lint tent of arginate of calcium.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Otorhinolaryngologic Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    571 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Surgiflo
    Arm Type
    Experimental
    Arm Description
    Using Surgiflo® (Absorbable Gelatin Hemostatic) for the post-operative haemostasis in endonasal surgery.
    Arm Title
    Floseal
    Arm Type
    Experimental
    Arm Description
    Using Floseal® (Absorbable Gelatin Hemostatic) containing human thrombin for the post-operative haemostasis in endonasal surgery
    Arm Title
    Algosteril
    Arm Type
    Experimental
    Arm Description
    Using Algosteril® (Hemostatic Sterile Wick) for the post-operative haemostasis in endonasal surgery
    Arm Title
    Abstention
    Arm Type
    No Intervention
    Arm Description
    Not using device for the post-operative haemostasis in endonasal surgery
    Intervention Type
    Device
    Intervention Name(s)
    Surgiflo
    Intervention Description
    using device during the endonasal surgery.
    Intervention Type
    Device
    Intervention Name(s)
    Floseal
    Intervention Description
    using device during the endonasal surgery.
    Intervention Type
    Device
    Intervention Name(s)
    Algosteril
    Intervention Description
    using device during the endonasal surgery.
    Primary Outcome Measure Information:
    Title
    Per-operative hemostasis
    Description
    Time needs to observe hemostasis after the device set up
    Time Frame
    Hours 0
    Title
    Hemostasis in the 6 first hours
    Description
    Number of compresses used from Hours 0 to Hours 6.
    Time Frame
    Hours 6
    Title
    Hemostasis at the 24th hour
    Description
    Algosteril arm (after having removed the wick): spontaneous observation of hemostasis in less that 3 min (yes/no) and needs to have a new intervention to stop bleedings (type) Surgiflo, Floseal, Abstention arms: time to observe hemostasis if bleedings occurred.
    Time Frame
    Hours 24
    Title
    Spontaneous hemorrhagic events
    Description
    number of spontaneous hemorrhagic events.
    Time Frame
    from Hours 0 to Day 45
    Secondary Outcome Measure Information:
    Title
    Preoperative assessment
    Description
    Preoperative scanner assessment with Lund ans Mackay score
    Time Frame
    Before the endonasal surgery
    Title
    Preoperative assessment
    Description
    Laboratory tests of hemostasis (platelets, fibrinogen...)
    Time Frame
    Hours 0
    Title
    Device evaluation by the surgeon
    Description
    time needs to set up the device
    Time Frame
    Hours 0
    Title
    Device evaluation by the surgeon
    Description
    subjective assessment of the implementation ease
    Time Frame
    Hours 0

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: endonasal surgery schedule Surgical indications: hypertrophic rhinitis, repeated or chronic infections, extraction of foreign body, polyposes naso-sinusal, benign tumors limited to the nasal pit and in sine, Exclusion Criteria: Pregnant Woman Disorder of the haemostasis known or disrupted preoperative biological balance assessment Use of treatment disrupting the blood coagulation (anti platelet, anti vitamin K, AINS) Unchecked HTA by the treatment and/or preoperative > mmHg 160/90 Surgical Act including a septoplasty malignant tumoral surgical Indication, or mild overtaking the naso-sinusial system Dacryocystorhinostomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laurent TAVERNIER, PH
    Organizational Affiliation
    CHU Besançon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Randomized Assessment of Devices Used to Prevent Post-operative Hemorrhagic Risk in Endonasal Surgery

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