Comparison of Chitodex Gel vs NexFoam on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis

February 13, 2024 updated by: Joseph Brunworth, MD, St. Louis University

Head to Head Comparison of Chitodex Gel With Triamcinolone vs NexFoam With Triamcinalone on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis (CRS)

The purpose of this study is to compare the efficacy and outcomes of Chitodex gel plus Kenalog versus Nexfoam plus Kenalog in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery. Both dressings are already known to be beneficial in controlling postoperative bleeding and promote wound healing.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The trial will be single blinded randomized controlled trial and patients recruited will undergo endoscopic sinus surgery as standard of care for treatment of CRS. Specific outcome measures will be objective and subjective outcome scores post surgery.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Recruiting
        • Saint Louis University
        • Contact:
        • Principal Investigator:
          • Joseph D Brunworth, MD
        • Sub-Investigator:
          • Jastin L Antisdel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

SLUCare Otolaryngology Clinic

Description

Inclusion Criteria:

  1. Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND
  2. ≥ 18 years to ≤ 90 years AND
  3. English speaking AND
  4. Able to give written informed consent AND
  5. Local residents who will be returning to this center for postoperative follow-up care AND
  6. Indicated to undergo endoscopic sinus surgery and willing to return at 2-4, 6-8 & 12 (± 2) weeks post-op.

Exclusion Criteria:

  1. allergy to shellfish
  2. pregnant or breastfeeding
  3. Hepatitis or blood disorders
  4. any drug allergy
  5. allergy to potato starch (due to Nexfoam)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chitogel
Chitodex gel plus Kenalog inserted into the middle meatus
Device: Chitogel
post-operative dressing within standard of care
Nexfoam
NexFoam plus Kenalog inserted into the middle meatus
Device: Nexfoam
post-operative dressing within standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Scores on Endoscopy
Time Frame: 12 (±2) weeks post surgery
Outcome measured based on the wound healing in the sinus openings made during surgery.
12 (±2) weeks post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Scores on Patients' Self-Directed Questionnaires
Time Frame: 12 (±2) weeks post surgery
Outcomes measured based on patients' personal symptom assessment.
12 (±2) weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Investigators

  • Principal Investigator: Joseph D Brunworth, MD, Department of Otolaryngology-Head & Neck Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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