Analysis of Hemostatic Agents Compared to Physiologic Hemostasis
NCT ID: NCT03068728
Last Updated: 2019-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2014-05-13
2017-04-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All Study Participants
Participants received hemostatic packing agent in one nasal cavity and no packing in the other.
Participants were randomized to one of three hemostatic packing agents (Arista, Nexfoam, Nasopore) through sealed envelope, chosen by surgeon prior to placement, with packing agent allocation and sidedness.
Arista
Nexfoam
Nasopore
Interventions
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Arista
Nexfoam
Nasopore
Eligibility Criteria
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Inclusion Criteria
-sinuses should have a similar degree of disease involvement bilaterally.
Exclusion Criteria
* history of underlying immunologic diseases, AIDS, cystic fibrosis, immunoglobulin deficiency, immotile cilia syndrome, and neutropenia,
* known hypersensitivity to the aforementioned agents,
* women who are pregnant or breastfeeding,
* anyone with a known allergy to any of the treatments (potato starch, iodine, shellfish)
* anyone with a known coagulopathy
18 Years
75 Years
ALL
No
Sponsors
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University of Kentucky
OTHER
St. Louis University
OTHER
Responsible Party
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Jastin Antisdel, MD
Assistant Professor
Principal Investigators
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Jastin L Antisdel, MD
Role: PRINCIPAL_INVESTIGATOR
St. Louis University
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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24331
Identifier Type: -
Identifier Source: org_study_id
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