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Completed

NCT Number: NCT01098578

Floseal Treatment for Posterior Epistaxis Study

Effectiveness of Floseal for the treatment of posterior epistaxis.

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Key information

Conditions

Epistaxis Hemorrhage Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Floseal

Drug

Received 1 syringe of Floseal as treatment for posterior epistaxis.

Other names: non applicable

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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%

Other outcomes

  1. Total Institutional Cost Savings

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

Floseal Posterior Epistaxis Pilot Study (PEPIS)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 2, 2010
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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