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

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT00406913
Collaborator
(none)
37
1
2
13
2.8

Study Details

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
  • Drug: mupirocin ointment
  • Other: SOC sterilization
N/A

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
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 :
Oct 1, 2005
Actual Primary Completion Date :
Nov 1, 2006
Actual Study Completion Date :
Nov 1, 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 [pre and post op]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00406913
Other Study ID Numbers:
  • 14208B
First Posted:
Dec 4, 2006
Last Update Posted:
Sep 5, 2013
Last Verified:
Sep 1, 2013
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2013