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

Otorhinolaryngologic Diseases Clinical Trial

— PRHEPOCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243344
• Other study ID #: SHC/2009/001/P
• Status: Completed
• Phase: N/A
• First received: August 2, 2017
• Last updated: August 4, 2017
• Start date: March 2010
• Est. completion date: May 2013

Study information

• Verified date: March 2010
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Otorhinolaryngologic Diseases

Intervention

Device:
• Surgiflo
using device during the endonasal surgery.
• Floseal
using device during the endonasal surgery.
• Algosteril
using device during the endonasal surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Per-operative hemostasis	Time needs to observe hemostasis after the device set up	Hours 0
Primary	Hemostasis in the 6 first hours	Number of compresses used from Hours 0 to Hours 6.	Hours 6
Primary	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
Primary	Spontaneous hemorrhagic events	number of spontaneous hemorrhagic events.	from Hours 0 to Day 45
Secondary	Preoperative assessment	Preoperative scanner assessment with Lund ans Mackay score	Before the endonasal surgery
Secondary	Preoperative assessment	Laboratory tests of hemostasis (platelets, fibrinogen...)	Hours 0
Secondary	Device evaluation by the surgeon	time needs to set up the device	Hours 0
Secondary	Device evaluation by the surgeon	subjective assessment of the implementation ease	Hours 0