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

Not Applicable

Completed

• Conditions: Otorhinolaryngologic Diseases
• Interventions: Device: Floseal; Device: Surgiflo; Device: Algosteril

• Registration Number: NCT03243344
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-04
• Last Update Submitted: 2017-08-04
• Study First Posted: 2017-08-09
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 571

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Floseal	Floseal	Using Floseal® (Absorbable Gelatin Hemostatic) containing human thrombin for the post-operative haemostasis in endonasal surgery
Surgiflo	Surgiflo	Using Surgiflo® (Absorbable Gelatin Hemostatic) for the post-operative haemostasis in endonasal surgery.
Algosteril	Algosteril	Using Algosteril® (Hemostatic Sterile Wick) for the post-operative haemostasis in endonasal surgery

Primary Outcome Measures

Name	Time	Method
Per-operative hemostasis	Hours 0	Time needs to observe hemostasis after the device set up
Hemostasis at the 24th hour	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.
Hemostasis in the 6 first hours	Hours 6	Number of compresses used from Hours 0 to Hours 6.
Spontaneous hemorrhagic events	from Hours 0 to Day 45	number of spontaneous hemorrhagic events.

Secondary Outcome Measures

Name	Time	Method
Device evaluation by the surgeon	Hours 0	subjective assessment of the implementation ease
Preoperative assessment	Hours 0	Laboratory tests of hemostasis (platelets, fibrinogen...)