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

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Otorhinolaryngologic Diseases

Treatments: Device: Algosteril; Device: Surgiflo; Device: Floseal

Study type: Interventional

Funder types: Other

Identifiers

NCT03243344

SHC/2009/001/P

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 571 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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571 participants in 4 patient groups

Surgiflo

Experimental group

Description:

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

Treatment:

Device: Surgiflo

Floseal

Experimental group

Description:

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

Treatment:

Device: Floseal

Algosteril

Experimental group

Description:

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

Treatment:

Device: Algosteril

Abstention

No Intervention group

Description:

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