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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.

Sponsored by: University of Chicago
Information provided by: University of Chicago
ClinicalTrials.gov Identifier: NCT00406913
  Purpose

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 Intervention
Endophthalmitis
Cataract Surgery
Prophylaxis
Drug: Mupirocin Nasal Ointment

MedlinePlus related topics:   Cataract    Eye Infections   

ChemIDplus related topics:   Salicylsalicylic acid    Sodium salicylate    Mupirocin    Mupirocin calcium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title:   Assessment of Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery Using Intranasal Mupirocin Ointment

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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.

Estimated Enrollment:   100
Study Start Date:   October 2005

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406913

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:

Study ID Numbers:   14208B
First Received:   November 30, 2006
Last Updated:   November 30, 2006
ClinicalTrials.gov Identifier:   NCT00406913
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Bacterial Infections
Eye Infections, Bacterial
Mupirocin
Eye Diseases
Eye Infections
Salicylsalicylic acid
Endophthalmitis
Sodium Salicylate
Lens Diseases
Mycoses
Uveitis
Cataract
Suppuration

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Uveal Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Uveitis, Suppurative
Eye Infections, Fungal
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2008




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