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

Terminated

• Conditions: Chronic Rhinosinusitis
• Interventions: Device: Nexfoam; Device: Chitogel

• Registration Number: NCT05083741
• Lead Sponsor: St. Louis University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Study Start: 2021-12-27
• Status Verified: 2024-08
• Primary Completion: 2024-08-08
• Study Completion: 2024-08-08
• Last Update Submitted: 2024-08-18
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nexfoam	Nexfoam	NexFoam plus Kenalog inserted into the middle meatus
Chitogel	Chitogel	Chitodex gel plus Kenalog inserted into the middle meatus

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Symptom Scores on Patients' Self-Directed Questionnaires	12 (±2) weeks post surgery	Outcomes measured based on patients' personal symptom assessment.

Trial Locations

Locations (1)

Saint Louis University; 🇺🇸 St. Louis, Missouri, United States