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

Saint Louis University (SLU)

Status: Terminated

Conditions: Chronic Rhinosinusitis

Treatments: Device: Nexfoam; Device: Chitogel

Study type: Observational

Funder types: Other

Identifiers

NCT05083741

31454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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)

Trial design

7 participants in 2 patient groups

Chitogel

Description:

Chitodex gel plus Kenalog inserted into the middle meatus

Treatment:

Device: Chitogel

Nexfoam

Description:

NexFoam plus Kenalog inserted into the middle meatus

Treatment:

Device: Nexfoam