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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Otorhinolaryngologic Diseases

Intervention / Treatment
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* Device: Surgiflo
* Device: Floseal
* Device: Algosteril


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgiflo<br>Using Surgiflo® (Absorbable Gelatin Hemostatic) for the post-operative haemostasis in endonasal surgery. | Device: Surgiflo<br>* using device during the endonasal surgery.<br>|
| Experimental: Floseal<br>Using Floseal® (Absorbable Gelatin Hemostatic) containing human thrombin for the post-operative haemostasis in endonasal surgery | Device: Floseal<br>* using device during the endonasal surgery.<br>|
| Experimental: Algosteril<br>Using Algosteril® (Hemostatic Sterile Wick) for the post-operative haemostasis in endonasal surgery | Device: Algosteril<br>* using device during the endonasal surgery.<br>|
| No Intervention: Abstention<br>Not using device for the post-operative haemostasis in endonasal surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per-operative hemostasis | Time needs to observe hemostasis after the device set up | Hours 0 | 
| Hemostasis in the 6 first hours | Number of compresses used from Hours 0 to Hours 6. | 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. | Hours 24 | 
| Spontaneous hemorrhagic events | number of spontaneous hemorrhagic events. | from Hours 0 to Day 45 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative assessment | Preoperative scanner assessment with Lund ans Mackay score | Before the endonasal surgery | 
| Preoperative assessment | Laboratory tests of hemostasis (platelets, fibrinogen...) | Hours 0 | 
| Device evaluation by the surgeon | time needs to set up the device | Hours 0 | 
| Device evaluation by the surgeon | subjective assessment of the implementation ease | Hours 0 |