Back to resultsEffectiveness of Antibiotic Delivery Via Bio-absorbable Sponge
Primary Purpose
Paranasal Sinus Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bacitracin
Sponsored by
About this trial
This is an interventional prevention trial for Paranasal Sinus Disease
Eligibility 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
Sites / Locations
- St. Elizabeth's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bacitracin
Saline
Arm Description
Nasopore sponge soaked in Bacitracin, no oral antibiotics
Nasopore sponge soaked in saline, routine oral antibiotics
Outcomes
Primary Outcome Measures
Rate of Infection
Number of participants without infections on post-op visits 90 days.
Secondary Outcome Measures
Full Information
NCT ID
NCT01222832
First Posted
October 14, 2010
Last Updated
May 2, 2017
Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01222832
Brief Title
Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge
Official Title
Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge After Functional Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Same as above
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paranasal Sinus Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bacitracin
Arm Type
Experimental
Arm Description
Nasopore sponge soaked in Bacitracin, no oral antibiotics
Arm Title
Saline
Arm Type
No Intervention
Arm Description
Nasopore sponge soaked in saline, routine oral antibiotics
Intervention Type
Drug
Intervention Name(s)
Bacitracin
Intervention Description
Bacitracin soaked nasopore sponge
Primary Outcome Measure Information:
Title
Rate of Infection
Description
Number of participants without infections on post-op visits 90 days.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Catalano, MD
Organizational Affiliation
Steward St. Elizabeth's Medical Center of Boston, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge
We'll reach out to this number within 24 hrs