Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery

• ClinicalTrials.gov Identifier: NCT00406913
• Recruitment Status: Completed
• First Posted: December 4, 2006
• Last Update Posted: September 5, 2013
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

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.

Condition or disease	Intervention/treatment	Phase
Endophthalmitis; Cataract Surgery; Prophylaxis	Drug: mupirocin ointment; Other: SOC sterilization	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Assessment of Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery Using Intranasal Mupirocin Ointment
• Study Start Date: October 2005
• Actual Primary Completion Date: November 2006
• Actual Study Completion Date: November 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mupirocin ointment	Drug: mupirocin ointment; Other: SOC sterilization
Active Comparator: Standard of Care sterilization	Other: SOC sterilization

Outcome Measures

Primary Outcome Measures :

1. Positive conjunctival culture [ Time Frame: pre and post op ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Illinois

University of Chicago Hospitals

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Investigators

• Principal Investigator: Seenu Hariprasad, MD; University of Chicago Hospitals

More Information

Publications:

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.

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.

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. doi: 10.1093/clinids/17.3.466.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00406913
• Other Study ID Numbers: 14208B
• First Posted: December 4, 2006
• Last Update Posted: September 5, 2013
• Last Verified: September 2013

Additional relevant MeSH terms:

Endophthalmitis; Cataract; Lens Diseases; Eye Diseases; Eye Infections; Infections; Mupirocin; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action