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

St. Louis University7 enrolled

Overview

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.

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

Conditions

Chronic Rhinosinusitis

Interventions

ChitogelDEVICE

post-operative dressing within standard of care

NexfoamDEVICE

post-operative dressing within standard of care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Locations (1)

Saint Louis University

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Clinical Scores on Endoscopy

Outcome measured based on the wound healing in the sinus openings made during surgery.

Time frame: 12 (±2) weeks post surgery

Secondary Outcomes

Symptom Scores on Patients' Self-Directed Questionnaires

Outcomes measured based on patients' personal symptom assessment.

Time frame: 12 (±2) weeks post surgery

Data from ClinicalTrials.gov

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