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Randomised controlled trial of prophylactic antibiotic treatment for the prevention of endophthalmitis after open globe injury at Groote Schuur Hospital
  1. N Du Toit,
  2. S Mustak,
  3. C Cook
  1. Department of Ophthalmology, University of Cape Town/Groote Schuur Hospital, Cape Town, Western Cape, South Africa
  1. Correspondence to A/Prof N Du Toit, Department of Ophthalmology, University of Cape Town/Groote Schuur Hospital, Ward D4, Anzio Road, Observatory, Cape Town, 7806, Western Cape, South Africa; nagib.dutoit{at}uct.ac.za; ndutoit{at}mweb.co.za

Abstract

Background/aims Most post-traumatic acute infectious endophthalmitis occur within a week of open globe trauma, necessitating early antibiotic prophylaxis. There are few randomised studies that demonstrate the benefits of prophylactic antibiotics. This randomised controlled non-inferiority trial was aimed at determining the incidence of post-traumatic endophthalmitis using established intravenous/oral prophylaxis and comparing this to the incidence using oral antibiotics only.

Methods All adult patients admitted with open globe injury were included. Those with proven endophthalmitis, high-risk features, who underwent primary evisceration and those allergic to the trial antibiotics were excluded. Patients were randomised to receive either intravenous cefazolin and oral ciprofloxacin or oral ciprofloxacin and oral cefuroxime for 3 days from admission. Acute endophthalmitis was the primary outcome. Patients completed the study if they were followed up for 6 weeks post injury.

Results Three hundred patients were enrolled, with 150 in each arm. There were 99 exclusions. Seven patients developed endophthalmitis despite prophylaxis—2.0% (three cases) in the intravenous and oral arm, compared with 2.7% (four cases) in the oral-only arm—this difference was not statistically significant (p=0.703).

Conclusions The incidence of endophthalmitis with prophylaxis was 2–3%. Selected patients with open globe injuries (without high-risk features) may receive either intravenous cefazolin and oral ciprofloxacin, or oral cefuroxime and oral ciprofloxacin as prophylaxis against acute endophthalmitis—the latter regimen has the advantage of shortening patients' hospital stays and reducing costs. Non-inferiority study-design limitations should be taken into account, however.

  • Trauma
  • Infection

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Footnotes

  • Contributors All the authors contributed towards: The design of the work and the interpretation of data; the drafting of the work; the final approval of the version for publication; the agreement to be accountable for all aspects of the work in terms of accuracy. NDT was the main author who did the write-up and submission. SM also contributed towards the acquisition of data and analysis. CC helped with revising the work critically.

  • Competing interests None declared.

  • Ethics approval Human Research Ethics Committee of University of cape Town.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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