Floseal Treatment for Posterior Epistaxis Study

Study Overview
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Brief Summary
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Effectiveness of Floseal for the treatment of posterior epistaxis.

Detailed Description
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Floseal, a hemostatic agent, is an effective treatment for anterior epistaxis as well as numerous other acute bleeding conditions throughout the body. The investigators hypothesize that Floseal is an effective treatment for posterior epistaxis. If so, then this will also lead to significant cost savings in comparison to any other method of treatment of posterior epistaxis. The investigators have planned a prospective, nonblinded, nonrandomised study with a total of 40 subjects with posterior epistaxis to be included in this study.

Official Title
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Floseal Posterior Epistaxis Pilot Study (PEPIS)

Conditions
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Epistaxis

Intervention / Treatment
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* Drug: Floseal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age greater than 18 years of age posterior epistaxis Exclusion Criteria: patients with anterior epistaxis known sensitivity to any of the materials of Floseal or the topical medications administered as part of the evaluation and treatment of epistaxis (lidocaine, xylometazoline hydrochloride) pregnant or breast feeding woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Floseal<br>Received 1 syringe of Floseal for treatment of posterior epistaxis. | Drug: Floseal<br>* Received 1 syringe of Floseal as treatment for posterior epistaxis.<br>* Other names: non applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Floseal for the Treatment of Posterior Epistaxis. | Successful treatment using the gelatin-thrombin matrix protocol (Floseal) was any case of posterior epistaxis that stopped following the immediate application of either one or two syringes of Floseal® and the epistaxis did not resume within fourteen days of the treatment date. | Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis. | The institutional cost for the treatment of posterior epistaxis patients with posterior packing, endoscopic surgery, and endovascular embolization, at TOH were calculated and compared with the institutional cost of a patient visit for posterior epistaxis successfully treated with the study protocol using Floseal. All costs were calculated in Canadian dollars (CAD), they were converted to US dollars (USD) using the current monetary exchange rate (total CAD x 1.03= total USD). For all of the patients treated in this study, the total institution cost was $24487.53 (USD). The minimal institutional cost of successfully treating all of the study patients with endoscopic surgery, would have been $53933.89 (USD) or 2.2 times the actual expense. (Total cost 20 participants Floseal/expected total cost 20 endoscopic surgery*100)This represents savings of $29446.39 (USD) or 45.40% | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posterior Epistaxis