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Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge

Information source: Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sinus Disease

Intervention: Bacitracin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Steward St. Elizabeth's Medical Center of Boston, Inc.

Official(s) and/or principal investigator(s):
Peter Catalano, MD, Principal Investigator, Affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.

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.

Clinical Details

Official title: Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge After Functional Endoscopic Sinus Surgery

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Efficacy

Detailed description: Same as above

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

St. Elizabeth's Medical Center, Brighton, Massachusetts 02135, United States
Additional Information

Starting date: July 2010
Last updated: January 2, 2014

Page last updated: August 20, 2015

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