Floseal Treatment for Posterior Epistaxis Study
Floseal Posterior Epistaxis Pilot Study (PEPIS)
2 other identifiers
interventional
20
0 countries
N/A
Brief Summary
Effectiveness of Floseal for the treatment of posterior epistaxis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
January 26, 2015
CompletedJanuary 26, 2015
January 1, 2015
1.6 years
April 1, 2010
June 4, 2013
January 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis.
30 days
Other Outcomes (1)
Total Institutional Cost Savings
End of study. Cost calculated after 20 patients were treated with Floseal
Study Arms (1)
Floseal
EXPERIMENTALReceived 1 syringe of Floseal for treatment of posterior epistaxis.
Interventions
Received 1 syringe of Floseal as treatment for posterior epistaxis.
Eligibility Criteria
You may qualify if:
- age greater than 18 years of age
- posterior epistaxis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 23754469DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Shaun Kilty
- Organization
- Ottawa Hospital Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Shaun Kilty, MD
Ottawa Hospital Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2010
First Posted
April 2, 2010
Study Start
April 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
January 26, 2015
Results First Posted
January 26, 2015
Record last verified: 2015-01