Floseal Treatment for Posterior Epistaxis Study
Primary Purpose
Epistaxis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Floseal
Sponsored by
About this trial
This is an interventional treatment trial for Epistaxis focused on measuring Posterior Epistaxis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Floseal
Arm Description
Received 1 syringe of Floseal for treatment of posterior epistaxis.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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%
Full Information
NCT ID
NCT01098578
First Posted
April 1, 2010
Last Updated
January 21, 2015
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01098578
Brief Title
Floseal Treatment for Posterior Epistaxis Study
Official Title
Floseal Posterior Epistaxis Pilot Study (PEPIS)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effectiveness of Floseal for the treatment of posterior epistaxis.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
Keywords
Posterior Epistaxis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Floseal
Arm Type
Experimental
Arm Description
Received 1 syringe of Floseal for treatment of posterior epistaxis.
Intervention Type
Drug
Intervention Name(s)
Floseal
Other Intervention Name(s)
non applicable
Intervention Description
Received 1 syringe of Floseal as treatment for posterior epistaxis.
Primary Outcome Measure Information:
Title
Effectiveness of Floseal for the Treatment of Posterior Epistaxis.
Description
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.
Time Frame
Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment.
Secondary Outcome Measure Information:
Title
Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis.
Description
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%
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Total Institutional Cost Savings
Description
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
Time Frame
End of study. Cost calculated after 20 patients were treated with Floseal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaun Kilty, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23754469
Citation
Kilty SJ, Al-Hajry M, Al-Mutairi D, Bonaparte JP, Duval M, Hwang E, Tse D. Prospective clinical trial of gelatin-thrombin matrix as first line treatment of posterior epistaxis. Laryngoscope. 2014 Jan;124(1):38-42. doi: 10.1002/lary.24240. Epub 2013 Jun 28.
Results Reference
derived
Links:
URL
http://www.ohri.ca
Description
Ottawa Hospital Research Institute
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Floseal Treatment for Posterior Epistaxis Study
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