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Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Jastin Antisdel, MD, St. Louis University
ClinicalTrials.gov Identifier:
NCT03068728
First received: February 20, 2017
Last updated: February 24, 2017
Last verified: February 2017
  Purpose
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 Intervention
Rhino Sinusitis Device: Arista Device: Nexafoam Device: Sinufoam Device: Nasopore Device: Posisep Hemostat Dressing Device: Posisep X Hemostat Dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
After sinus sugery, 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

Resource links provided by NLM:


Further study details as provided by Jastin Antisdel, MD, St. Louis University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 144
Actual Study Start Date: May 13, 2014
Estimated Study Completion Date: March 31, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arista Device: Arista
Active Comparator: Nexafoam Device: Nexafoam
Active Comparator: Sinufoam Device: Sinufoam
Active Comparator: Nasopore Device: Nasopore
Active Comparator: Posisep Hemostat Dressing Device: Posisep Hemostat Dressing
Active Comparator: Posisep X Hemostat Dressing Device: Posisep X Hemostat Dressing

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03068728

Sponsors and Collaborators
St. Louis University
Investigators
Principal Investigator: Jastin L Antisdel, MD St. Louis University
  More Information

Responsible Party: Jastin Antisdel, MD, Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT03068728     History of Changes
Other Study ID Numbers: 24331
Study First Received: February 20, 2017
Last Updated: February 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jastin Antisdel, MD, St. Louis University:
bilateral chronic rhino sinusitis

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on August 18, 2017