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Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

Sponsor
St. Louis University (Other)
Overall Status
Completed
CT.gov ID
NCT03068728
Collaborator
University of Kentucky (Other)
62
Enrollment
1
Arm
34.9
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Arista
  • Device: Nexfoam
  • Device: Nasopore
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Analysis of Hemostatic Agents Compared to Physiologic Hemostasis
Actual Study Start Date :
May 13, 2014
Actual Primary Completion Date :
Apr 10, 2017
Actual Study Completion Date :
Apr 10, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: All Study Participants

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • St. Louis University
  • University of Kentucky

Investigators

  • Principal Investigator: Jastin L Antisdel, MD, St. Louis University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Jastin Antisdel, MD, Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier:
NCT03068728
Other Study ID Numbers:
  • 24331
First Posted:
Mar 3, 2017
Last Update Posted:
Apr 4, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Jastin Antisdel, MD, Assistant Professor, St. Louis University
bilateral chronic rhino sinusitis
Additional relevant MeSH terms:
Sinusitis

Study Results

No Results Posted as of Apr 4, 2019