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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgiflo | Experimental | Using Surgiflo® (Absorbable Gelatin Hemostatic) for the post-operative haemostasis in endonasal surgery. |
|
| Floseal | Experimental | Using Floseal® (Absorbable Gelatin Hemostatic) containing human thrombin for the post-operative haemostasis in endonasal surgery |
|
| Algosteril | Experimental | Using Algosteril® (Hemostatic Sterile Wick) for the post-operative haemostasis in endonasal surgery |
|
| Abstention | No Intervention | Not using device for the post-operative haemostasis in endonasal surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgiflo | Device | using device during the endonasal surgery. |
| |
| 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 |
| Hours 24 |
| Spontaneous hemorrhagic events | number of spontaneous hemorrhagic events. | from Hours 0 to Day 45 |
| 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...) |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent TAVERNIER, PH | CHU Besançon | Principal Investigator |
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| ID | Term |
|---|---|
| D010038 | Otorhinolaryngologic Diseases |
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| Floseal |
| Device |
using device during the endonasal surgery. |
|
| Algosteril | Device | using device during the endonasal surgery. |
|
| 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 |