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Completed

NCT Number: NCT03243344

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

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 .

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Key information

Conditions

Otorhinolaryngologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgiflo

Device

using device during the endonasal surgery.

Floseal

Device

using device during the endonasal surgery.

Algosteril

Device

using device during the endonasal surgery.

Primary outcomes

  1. Per-operative hemostasis

    Time frame: Hours 0

    Time needs to observe hemostasis after the device set up

  2. Hemostasis in the 6 first hours

    Time frame: Hours 6

    Number of compresses used from Hours 0 to Hours 6.

  3. Hemostasis at the 24th hour

    Time frame: Hours 24

    • 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.

  4. Spontaneous hemorrhagic events

    Time frame: from Hours 0 to Day 45

    number of spontaneous hemorrhagic events.

Secondary outcomes

  1. Preoperative assessment

    Time frame: Before the endonasal surgery

    Preoperative scanner assessment with Lund ans Mackay score

  2. Preoperative assessment

    Time frame: Hours 0

    Laboratory tests of hemostasis (platelets, fibrinogen...)

  3. Device evaluation by the surgeon

    Time frame: Hours 0

    time needs to set up the device

  4. Device evaluation by the surgeon

    Time frame: Hours 0

    subjective assessment of the implementation ease

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Randomized Medico-economic Assessment of Preventive Devices Used for Post-operative Hemorrhagic Risk in Endonasal Surgery

Acronym: PRHEPOCE

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2017
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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