Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery
Primary Purpose
Endophthalmitis, Cataract Surgery, Prophylaxis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mupirocin ointment
SOC sterilization
Sponsored by
About this trial
This is an interventional prevention trial for Endophthalmitis
Eligibility Criteria
Inclusion Criteria:
- Included in the study will be any patient eligible for cataract or vitrectomy surgery. No populations will be excluded on the basis of demographics.
Exclusion Criteria:
- Excluded will be those patients who have known sensitivity or allergy to mupirocin ointment, or patients using topical ocular or systemic antibiotics during a two week period prior to entry into the study. Additionally, patient's using topical corticosteroids will be excluded as well
Sites / Locations
- University of Chicago Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mupirocin ointment
Standard of Care sterilization
Arm Description
Outcomes
Primary Outcome Measures
Positive conjunctival culture
Secondary Outcome Measures
Full Information
NCT ID
NCT00406913
First Posted
November 30, 2006
Last Updated
September 4, 2013
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00406913
Brief Title
Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery
Official Title
Assessment of Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery Using Intranasal Mupirocin Ointment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the conjunctival flora prior to cataract or vitrectomy surgery comparing mupirocin ointment applied to the conjunctiva along with standard ocular sterilization vs. standard ocular sterilization alone.
Detailed Description
Bacterial endophthalmitis is a rare but devastating complication of intraocular surgery. Given the devastating ocular sequelae of endophthalmitis, one cannot underestimate the need to develop a sterilization strategy which most effectively prevents intraocular infection. The most common organisms causing bacterial postoperative endophthalmitis are gram-positive cocci, particularly coagulase-negative staphylococci and Staphylococcus Aureus. It is thought that the most common sources of bacterial contamination predisposing to endophthalmitis are the eyelids and conjunctiva (Ariyasu).
The two main techniques used to reduce the bacterial flora on the ocular surface include treatment of the ocular surface with topical antibiotics prior to surgery and the instillation of 5% povidone-iodine during the prep immediately prior to beginning the surgical procedure (Speaker). Mupirocin ointment is a logical choice for surgical prophylaxis as it has been reported that mupirocin treatment applied to the nose resulted in elimination rates (of S. Aureus from the nares) of 91% directly after therapy (Doebbeling). Use of mupirocin ointment applied to the nares prior to eye surgery resulted in a significant decrease in the bacterial load on the conjunctiva at the time of surgery (Alexandrou, in press). Using mupirocin ointment directly to the conjunctiva, in addition to standard ocular sterilization techniques, may result in an even greater decrease in conjunctival flora prior to eye surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endophthalmitis, Cataract Surgery, Prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mupirocin ointment
Arm Type
Experimental
Arm Title
Standard of Care sterilization
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
mupirocin ointment
Intervention Type
Other
Intervention Name(s)
SOC sterilization
Primary Outcome Measure Information:
Title
Positive conjunctival culture
Time Frame
pre and post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Included in the study will be any patient eligible for cataract or vitrectomy surgery. No populations will be excluded on the basis of demographics.
Exclusion Criteria:
Excluded will be those patients who have known sensitivity or allergy to mupirocin ointment, or patients using topical ocular or systemic antibiotics during a two week period prior to entry into the study. Additionally, patient's using topical corticosteroids will be excluded as well
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seenu Hariprasad, MD
Organizational Affiliation
University of Chicago Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1775308
Citation
Speaker MG, Menikoff JA. Prophylaxis of endophthalmitis with topical povidone-iodine. Ophthalmology. 1991 Dec;98(12):1769-75. doi: 10.1016/s0161-6420(91)32052-9.
Results Reference
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PubMed Identifier
15750752
Citation
Kluytmans JA, Wertheim HF. Nasal carriage of Staphylococcus aureus and prevention of nosocomial infections. Infection. 2005 Feb;33(1):3-8. doi: 10.1007/s15010-005-4012-9.
Results Reference
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PubMed Identifier
8336886
Citation
Ariyasu RG, Nakamura T, Trousdale MD, Smith RE. Intraoperative bacterial contamination of the aqueous humor. Ophthalmic Surg. 1993 Jun;24(6):367-73; discussion 373-4.
Results Reference
background
PubMed Identifier
8218691
Citation
Doebbeling BN, Breneman DL, Neu HC, Aly R, Yangco BG, Holley HP Jr, Marsh RJ, Pfaller MA, McGowan JE Jr, Scully BE, et al. Elimination of Staphylococcus aureus nasal carriage in health care workers: analysis of six clinical trials with calcium mupirocin ointment. The Mupirocin Collaborative Study Group. Clin Infect Dis. 1993 Sep;17(3):466-74. doi: 10.1093/clinids/17.3.466.
Results Reference
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Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery
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