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Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge

This study is currently recruiting participants.
Verified July 2011 by Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor:
Information provided by (Responsible Party):
Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT01222832
First received: October 14, 2010
Last updated: February 2, 2012
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Sinus Disease
 Drug: Bacitracin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge After Functional Endoscopic Sinus Surgery

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Steward St. Elizabeth's Medical Center of Boston, Inc.:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To evaluate the efficacy of a nasopore sponge soaked with Bacitracin only Verses a saline soaked sponge and oral antibiotics


Estimated Enrollment: 250
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental single arm
Nasopore sponge soaked in Bacitracin
 Drug: Bacitracin
Bacitracin soaked sponge
Other Name: Bacitracin

Detailed Description:

Same as above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222832

Locations
United States, Massachusetts
St. Elizabeth's Medical Center Recruiting
Brighton, Massachusetts, United States, 02135
Contact: Peter Catalano, MD     617-789-5004     peter.catalano@steward.org    
Contact: Robert A Keller, RN/CRNA     1-617-779-6455     robert.keller@steward.org    
Principal Investigator: Peter Catalano, MD            
Sponsors and Collaborators
Steward St. Elizabeth's Medical Center of Boston, Inc.
Investigators
Principal Investigator: Peter Catalano, MD Steward St. Elizabeth's Medical Center of Boston, Inc.
  More Information

No publications provided

Responsible Party: Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier: NCT01222832     History of Changes
Other Study ID Numbers: 00534
Study First Received: October 14, 2010
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Bacterial Agents
Bacitracin
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on June 18, 2013