Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

Saint Louis University (SLU)

Status: Completed

Conditions: Rhino Sinusitis

Treatments: Device: Nexfoam; Device: Nasopore; Device: Arista

Study type: Interventional

Funder types: Other

Identifiers

NCT03068728

24331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

All Study Participants

Other group

Description:

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.

Treatment:

Device: Nexfoam

Device: Nasopore

Device: Arista