Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge

Sinus Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222832
• Other study ID #: 00534
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2010
• Last updated: January 2, 2014
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: July 2011
• Source: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Same as above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Sinus Disease

Intervention

Drug:
• Bacitracin
Bacitracin soaked sponge

Locations

Country	Name	City	State
United States	St. Elizabeth's Medical Center	Brighton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Steward St. Elizabeth's Medical Center of Boston, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	To evaluate the efficacy of a nasopore sponge soaked with Bacitracin only Verses a saline soaked sponge and oral antibiotics	3 months	No