Otorhinolaryngologic Diseases
Conditions
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 frost(gel) containing of the thrombin. Algosteril® is a lint tent of arginate of calcium.
Interventions
DEVICESurgiflo
using device during the endonasal surgery.
DEVICEFloseal
using device during the endonasal surgery.
DEVICEAlgosteril
using device during the endonasal surgery.
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Per-operative hemostasis | Hours 0 | Time needs to observe hemostasis after the device set up |
| Hemostasis in the 6 first hours | Hours 6 | Number of compresses used from Hours 0 to Hours 6. |
| Hemostasis at the 24th hour | Hours 24 | * 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. |
| Spontaneous hemorrhagic events | from Hours 0 to Day 45 | number of spontaneous hemorrhagic events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative assessment | Before the endonasal surgery | Preoperative scanner assessment with Lund ans Mackay score |
| Device evaluation by the surgeon | Hours 0 | time needs to set up the device |
Outcome results
None listed