Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

NCT ID: NCT03068728

Last Updated: 2019-04-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-13

Study Completion Date

2017-04-10

Brief Summary

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This study is a prospective comparison between absorbable hemostatic agents as a group and the body's natural hemostatic ability without aid of therapy in patients undergoing bilateral sinus surgery with or without septoplasty.

Detailed Description

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The purpose of this study is to evaluate the efficacy of absorbable hemostatic agents in comparison with physiologic hemostasis after endoscopic sinus surgery. The investigators aim to determine the relative efficacy of hemostatic agents to halt epistaxis and compare this with the degree of epistaxis observed without therapy and evaluate objective healing parameters.

Conditions

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Rhino Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

After sinus surgery, the surgeon will randomize the patient to one of six hemostatic agents and place that product in one sinus cavity, while leaving the other sinus cavity without packing. The treatment group will be compared to control.
Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type OTHER

Arista

Intervention Type DEVICE

Nexfoam

Intervention Type DEVICE

Nasopore

Intervention Type DEVICE

Interventions

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Arista

Intervention Type DEVICE

Nexfoam

Intervention Type DEVICE

Nasopore

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

-≥18 to \<75 years of age with bilateral chronic or recurrent rhino sinusitis recalcitrant to medical therapy that requires endoscopic sinus surgery

-sinuses should have a similar degree of disease involvement bilaterally.

Exclusion Criteria

* massive sinonasal polyposis,
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kentucky

OTHER

Sponsor Role collaborator

St. Louis University

OTHER

Sponsor Role lead

Responsible Party

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Jastin Antisdel, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

View Document

Other Identifiers

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24331

Identifier Type: -

Identifier Source: org_study_id

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