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Outcome Measures

Primary Outcomes (1)

Number of participants with superior healing qualities after use of hemostatic agents compared to physiologic hemostasis after endoscopic sinus surgery.
Participants will be monitored for 6 weeks. Means and standard deviations will be obtained for data collected from patient surveys rating subjective symptoms such as nasal obstruction, bleeding, pain, and nasal discharge on a scale ranging from 1-10 and investigator surveys evaluating the qualities of the patient's recovery (synechiae formation, granulation, edema, infection, and time spent debriding the sinuses) in response to intervention and compare this with the degree of epistaxis observed without therapy.
6 weeks post-operative

Study Arms (1)

All Study Participants

OTHER

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.

Device: AristaDevice: NexfoamDevice: Nasopore

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

≥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.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Purpose

TREATMENT

Intervention Model

SINGLE GROUP

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Assistant Professor

Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

All Study Participants

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

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Source record

Documents

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

All Study Participants

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents