Status:
COMPLETED
Randomized Assessment of Devices Used to Prevent Post-operative Hemorrhagic Risk in Endonasal Surgery
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Otorhinolaryngologic Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
571 Patients enrolled
Trial Details
Trial ID
NCT03243344
Start Date
March 1 2010
End Date
May 1 2013
Last Update
August 9 2017
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