search
Back to results

Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

Primary Purpose

Rhino Sinusitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arista
Nexfoam
Nasopore
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhino Sinusitis focused on measuring bilateral chronic rhino sinusitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    All Study Participants

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 20, 2017
    Last Updated
    April 2, 2019
    Sponsor
    St. Louis University
    Collaborators
    University of Kentucky
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03068728
    Brief Title
    Analysis of Hemostatic Agents Compared to Physiologic Hemostasis
    Official Title
    Analysis of Hemostatic Agents Compared to Physiologic Hemostasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 13, 2014 (Actual)
    Primary Completion Date
    April 10, 2017 (Actual)
    Study Completion Date
    April 10, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Louis University
    Collaborators
    University of Kentucky

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhino Sinusitis
    Keywords
    bilateral chronic rhino sinusitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    All Study Participants
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Arista
    Intervention Type
    Device
    Intervention Name(s)
    Nexfoam
    Intervention Type
    Device
    Intervention Name(s)
    Nasopore
    Primary Outcome Measure Information:
    Title
    Number of participants with superior healing qualities after use of hemostatic agents compared to physiologic hemostasis after endoscopic sinus surgery.
    Description
    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.
    Time Frame
    6 weeks post-operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jastin L Antisdel, MD
    Organizational Affiliation
    St. Louis University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Analysis of Hemostatic Agents Compared to Physiologic Hemostasis

    We'll reach out to this number within 24 hrs