Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery

Not Applicable

Withdrawn

• Conditions: Sinusitis; Chronic Sinusitis
• Interventions: Procedure: Nasopore sponge soaked with saline; Drug: Bacitracin

• Registration Number: NCT00705354
• Lead Sponsor: Lahey Clinic

Brief Summary

This study will compare the incidence of post-op infection after sinus surgery using conventional post-op oral antibiotics to the incidence of infection after sinus surgery when a bio-resorbable antibiotic soaked nasal sponge is used in the nasal cavity in lieu of post-op oral antibiotics. The nasal sponge is a routine nasal dressing used after sinus surgery and will therefore be placed in all patients.

Detailed Description

Sinusitis affects 37 million people each year making it one of the most common health problems in the United States. It has a large impact in direct healthcare expenditures, significant loss of workplace productivity and a greater impact on quality of life than diabetes or congestive heart failure.

The most frequently used treatments are medications and/or Functional Endoscopic Sinus Surgery(FESS). 100 subjects undergoing ESS will participate, randomized into two groups, treatment and control. All subjects will have a Nasopore sponge placed into the middle meatus of the nose at the end of the procedure(The sponge is FDA approved and commonly used. Subjects in the treatment group will receive a Nasopore sponge soaked in Bacitracin solution. These subjects will not receive oral antibiotics post-operatively. The control group subjects will have a saline soaked Nasopore sponge laced during surgery and will receive routine oral antibiotics post-operatively. The hypothesis is that subjects who receive the antibiotic soaked nasal sponge in lieu of saline soaked nasal sponge will have infection rates comparable to those who receive systemic antibiotics, but because they will not receive systemic antibiotics, the treated group will have fewer side effects and the cost to treat them will be less.

Study Timeline

• Study First Submitted: 2008-06-24
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Study Start: 2009-01
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-12
• Last Update Posted: 2012-04-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subjects requiring Endoscopic Sinus Surgery

Exclusion Criteria

• Pediatric subjects <18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nasopore sponge soaked with saline	Control group undergoing standard ESS will have a saline soaked Nasopore sponge placed during surgery and will receive routine oral antibiotics post-operatively
2	Bacitracin	Treatment group undergoing ESS will have Nasopore sponge soaked with Bacitracin, but will not receive oral antibiotics post-operatively

Primary Outcome Measures

Name	Time	Method
The two groups of subjects will be compared on clincal & demographic characteristics. Evaluation of any new infection (no or yes).	Post surgical evaluations at 2/3 weeks and 3 months

Secondary Outcome Measures

Name	Time	Method
Clinical and demographic data will be evaluate presence/absence of inflammation of surrounding, adhesions, pain, granulation tissue	Evaluated at 2/3 weeks and 3 months

Trial Locations

Locations (1)

Lahey Clinic, Inc.; 🇺🇸 Burlington, Massachusetts, United States