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PHARMACOKINETICS IN HUMANS OF A GENTAMICIN-LOADED FLEECE, GARACOL®, IN ACUTE PERIPROSTHETIC INFECTION: AN IN VIVO STUDY



Abstract

Although bovine carriers of antibiotics are generally accepted in the treatment of local infections, a literature search in PubMed, Medline and Embase up to April 2006 did not reveal any information on the human pharmacokinetics on Garacol®, a bovine carrier containing the equivalent of 130 mg gentamicin sulphate, on the market since 1995. The purpose of this study was to describe the human in vivo pharmacokinetics of Garacol®.

A cohort of 19 consecutive patients with an acute periprosthetic infection to which 2 to 5 fleeces were applied in each case.

Initially, the concentration in blood increased to 3.2–7.2 mg/L depending on the number of fleeces that were applied. The serum peak concentrations resulted in peak/MIC ratios of 2.5–36 for P. aeruginosa, S. aureus and Klebsiella spp. Peak gentamicin levels in the exudate are bactericidal for several days, even for gentamicin-resistant micro-organisms. Subsequently, the serum values decreased almost linearly below 0.3 mg/L in 18 to 62 hours. After 24 hours the gentamicin serum levels dropped below the threshold for toxicity of 2 mg/L. Comparison is made between the difference in pharmacokinetic behaviour of the Garacol® drug with Septocoll® and conventional and mini PMMA beads.

The conclusion is that collagen-loaded fleeces may be useful as an adjuvant treatment of implant-related infections.



Correspondence should be addressed to Vasiliki Boukouvala at Department of Orthopaedic Surgery & Traumatology, University Hospital of Larissa, 110 Mezourlo, Larissa, GREECE. Tel: +30 2410 682722, Fax: +30 2410 670107, Email: malizos@med.uth.gr