Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery
Information source: University of Chicago
Information obtained from ClinicalTrials.gov on June 20, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endophthalmitis; Cataract Surgery; Prophylaxis
Intervention: Mupirocin Nasal Ointment (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Chicago Official(s) and/or principal investigator(s): Seenu Hariprasad, MD, Principal Investigator, Affiliation: University of Chicago Hospitals
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.
Clinical Details
Official title: Assessment of Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery Using Intranasal Mupirocin Ointment
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Primary outcome: To see if the use of mupirocin nasal ointment, along with standard eye sterilization prior to surgery, will decrease the incidence of eye infection after cataract surgery.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Chicago Hospitals, Chicago, Illinois 60637, United States
Additional Information
Related publications: Speaker MG, Menikoff JA. Prophylaxis of endophthalmitis with topical povidone-iodine. Ophthalmology. 1991 Dec;98(12):1769-75. Kluytmans JA, Wertheim HF. Nasal carriage of Staphylococcus aureus and prevention of nosocomial infections. Infection. 2005 Feb;33(1):3-8. Review. 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. 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.
Starting date: October 2005
Last updated: November 30, 2006
|