Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

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.

Completed

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Key information

Conditions

Rhino Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinosinusitis Sinusitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARISTA

Device

Nexfoam

Device

nasopore

Device

Primary outcomes

Number of participants with superior healing qualities after use of hemostatic agents compared to physiologic hemostasis after endoscopic sinus surgery.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Collaborators

University of Kentucky

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Mar 3, 2017
Registry last updated: Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed