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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00406913
First received: November 30, 2006
Last updated: September 4, 2013
Last verified: September 2013

November 30, 2006
September 4, 2013
October 2005
November 2006   (final data collection date for primary outcome measure)
Positive conjunctival culture [ Time Frame: pre and post op ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00406913 on ClinicalTrials.gov Archive Site
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Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery
Assessment of Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery Using Intranasal Mupirocin Ointment

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
  • Endophthalmitis
  • Cataract Surgery
  • Prophylaxis
  • Drug: mupirocin ointment
  • Other: SOC sterilization
  • Experimental: Mupirocin ointment
    Interventions:
    • Drug: mupirocin ointment
    • Other: SOC sterilization
  • Active Comparator: Standard of Care sterilization
    Intervention: Other: SOC sterilization

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00406913
14208B
Not Provided
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Seenu Hariprasad, MD University of Chicago Hospitals
University of Chicago
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP