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Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Catalano, Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT01222832
First received: October 14, 2010
Last updated: May 2, 2017
Last verified: May 2017
  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
Paranasal Sinus Disease Drug: Bacitracin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge After Functional Endoscopic Sinus Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate of Infection [ Time Frame: 90 days ]
    Number of participants without infections on post-op visits 90 days.


Enrollment: 226
Study Start Date: July 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bacitracin
Nasopore sponge soaked in Bacitracin, no oral antibiotics
Drug: Bacitracin
Bacitracin soaked nasopore sponge
No Intervention: Saline
Nasopore sponge soaked in saline, routine oral antibiotics

Detailed Description:
Same as above
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222832

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

Responsible Party: Peter Catalano, Chief of Otolaryngology, 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
Results First Received: May 19, 2015
Last Updated: May 2, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Bacitracin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on June 28, 2017