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

NCT ID: NCT00406913

Last Updated: 2013-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-11-30

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.

Conditions

Endophthalmitis; Cataract Surgery; Prophylaxis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Mupirocin ointment

Group Type: EXPERIMENTAL

mupirocin ointment

Intervention Type: DRUG

SOC sterilization

Intervention Type: OTHER

Standard of Care sterilization

Group Type: ACTIVE_COMPARATOR

SOC sterilization

Intervention Type: OTHER

Interventions

mupirocin ointment

Intervention Type: DRUG

SOC sterilization

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seenu Hariprasad, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago Hospitals

Locations

University of Chicago Hospitals

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 1775308 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15750752 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8336886 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8218691 (View on PubMed)

Other Identifiers

14208B

Identifier Type: -

Identifier Source: org_study_id