Trial Outcomes & Findings for Floseal Treatment for Posterior Epistaxis Study (NCT NCT01098578)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment.

Results posted on

2015-01-26

Participant Flow

Patients who presented to the emergency department with posterior epistaxis or who were already admitted to hospital for another diagnosis and had posterior epistaxis were offered enrollment. Recruitment period April 2010- April 2012

Participant milestones

Participant milestones
Measure	Floseal. Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Floseal Treatment for Posterior Epistaxis Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Floseal n=20 Participants Received Floseal treatment for posterior epistaxis. Floseal : Received Floseal as treatment for posterior epistaxis.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants
Age, Continuous	57.8 years STANDARD_DEVIATION 20.06 • n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Region of Enrollment Canada	20 participants n=99 Participants

PRIMARY outcome

Timeframe: Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment.

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.

Outcome measures

Outcome measures
Measure	Floseal n=20 Participants Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion	Endoscopic Surgery The calculated minimal institutional cost if all the study patients had been treated with endoscopic surgery for posterior epistaxis
Effectiveness of Floseal for the Treatment of Posterior Epistaxis.	20 participants	—

SECONDARY outcome

Timeframe: 30 days

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%

Outcome measures

Outcome measures
Measure	Floseal n=20 Participants Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion	Endoscopic Surgery The calculated minimal institutional cost if all the study patients had been treated with endoscopic surgery for posterior epistaxis
Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis.	45.40 percentage of expected cost	—

OTHER_PRE_SPECIFIED outcome

Timeframe: End of study. Cost calculated after 20 patients were treated with Floseal

Difference between the total institutional cost of successfully treating 20 study patients with Floseal compared to the total institutional cost of treating the same number of patient with endoscopic surgery

Outcome measures

Outcome measures
Measure	Floseal n=20 Participants Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion	Endoscopic Surgery n=20 Participants The calculated minimal institutional cost if all the study patients had been treated with endoscopic surgery for posterior epistaxis
Total Institutional Cost Savings	24487.53 US Dollars	53933.89 US Dollars

Adverse Events

Floseal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shaun Kilty

Ottawa Hospital Research Institute

Phone: 613-798-5555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place