Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

Not Applicable

Completed

• Conditions: Rhino Sinusitis
• Interventions: Device: Arista; Device: Nexfoam; Device: Nasopore

• Registration Number: NCT03068728
• Lead Sponsor: St. Louis University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-05-13
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-03
• Primary Completion: 2017-04-10
• Study Completion: 2017-04-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Study Participants	Arista	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.
All Study Participants	Nasopore	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.
All Study Participants	Nexfoam	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with superior healing qualities after use of hemostatic agents compared to physiologic hemostasis after endoscopic sinus surgery.	6 weeks post-operative	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.