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Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge

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ClinicalTrials.gov Identifier: NCT01222832
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Catalano, 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.

Condition or disease Intervention/treatment Phase
Paranasal Sinus Disease Drug: Bacitracin Phase 2

Detailed Description:
Same as above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge After Functional Endoscopic Sinus Surgery
Study Start Date : July 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
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



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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

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
First Posted: October 18, 2010    Key Record Dates
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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