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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05083741

Enrollment

Registered

2021-10-19

Start date

2021-12-27

Completion date

2024-08-08

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis

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.

Interventions

DEVICEChitogel

post-operative dressing within standard of care

DEVICENexfoam

post-operative dressing within standard of care

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026