Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

NCT03068728 | Completed

• 1 other identifier: 24331
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhino Sinusitis

Keywords

bilateral chronic rhino sinusitis

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: Arista; Device: Nexfoam; Device: Nasopore

Interventions

Arista DEVICE

All Study Participants

Nexfoam DEVICE

All Study Participants

Nasopore DEVICE

All Study Participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead
• University of Kentucky: collaborator

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jastin L Antisdel, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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.

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 3, 2017
• Study Start: May 13, 2014
• Primary Completion: April 10, 2017
• Study Completion: April 10, 2017
• Last Updated: April 4, 2019

Record last verified: 2019-04