Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge

Phase 2

Completed

• Conditions: Paranasal Sinus Disease
• Interventions: Drug: Bacitracin

• Registration Number: NCT01222832
• Lead Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.

Brief Summary

This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a sponge soaked in Saline / and the administration of oral antibiotics.

Detailed Description

Same as above

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2015-05-19
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-02
• Last Update Submitted: 2017-05-02
• Results First Posted: 2017-05-31
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• Patient having primary or revision sinus surgery. Aged 18 years or older.Patients must have middle meatus easily identified. The type of surgery will not be influenced by the participation in this study.

Exclusion Criteria

• Age less then 18
• Known sensitivity to Bacitracin
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacitracin	Bacitracin	Nasopore sponge soaked in Bacitracin, no oral antibiotics

Primary Outcome Measures

Name	Time	Method
Rate of Infection	90 days	Number of participants without infections on post-op visits 90 days.

Trial Locations

Locations (1)

St. Elizabeth's Medical Center; 🇺🇸 Brighton, Massachusetts, United States