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

NCT03243344 | Completed DMC

• 1 other identifier: SHC/2009/001/P
• Study Type: interventional
• Target: 571
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Otorhinolaryngologic Diseases

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Preoperative assessment

  Before the endonasal surgery

• Preoperative assessment

  Hours 0

• Device evaluation by the surgeon

  Hours 0

• Device evaluation by the surgeon

  Hours 0

Study Arms (4)

Surgiflo

EXPERIMENTAL

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

Device: Surgiflo

Floseal

EXPERIMENTAL

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

Device: Floseal

Algosteril

EXPERIMENTAL

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

Device: Algosteril

Abstention

NO INTERVENTION

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

Interventions

Surgiflo DEVICE

using device during the endonasal surgery.

Surgiflo

Floseal DEVICE

using device during the endonasal surgery.

Floseal

Algosteril DEVICE

using device during the endonasal surgery.

Algosteril

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Otorhinolaryngologic Diseases

Study Officials

• Laurent TAVERNIER, PH

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 9, 2017
• Study Start: March 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 9, 2017

Record last verified: 2010-03