Clinical Trial: Floseal Treatment for Posterior Epistaxis Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Floseal Posterior Epistaxis Pilot Study (PEPIS)

Brief Summary: Effectiveness of Floseal for the treatment of posterior epistaxis.

Detailed Summary: 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.
Sponsor: Ottawa Hospital Research Institute

Current Primary Outcome: Effectiveness of Floseal for the Treatment of Posterior Epistaxis. [ Time Frame: 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.


Original Primary Outcome: Effectiveness of Floseal for the Treatment of Posterior Epistaxis. [ Time Frame: Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment. ]

Current Secondary Outcome: Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis. [ Time Frame: 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%


Original Secondary Outcome: Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis. [ Time Frame: 30 days ]

Information By: Ottawa Hospital Research Institute

Dates:
Date Received: April 1, 2010
Date Started: April 2010
Date Completion:
Last Updated: January 21, 2015
Last Verified: January 2015