Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

Rhino Sinusitis Clinical Trial

Official title:

Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068728
• Other study ID #: 24331
• Status: Completed
• Phase: N/A
• Start date: May 13, 2014
• Est. completion date: April 10, 2017

Study information

• Verified date: April 2019
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 10, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhino Sinusitis
• Sinusitis

Intervention

Device:
• Arista

• Nexfoam

• Nasopore

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
St. Louis University	University of Kentucky

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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