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.
From Mars 1997 till July 2003 we subsequent included 32 patients, 26 with a minimal follow-up of 2 years are presented in this study. We evaluated the results of the treatment prospectively. The inflammatory parameters; C-reactive protein, erythrocyte sedimentation rate and white blood cell count (before and after debridement) The Harris Hip Score and radiograms were monitored multiple times.
In 23 patients the infection did not re-appear. The C-reactive protein normalised from a mean of 103 (2–320) to lower than 5 at 2 years, the erythrocyte sedimentation rate from 72 (14–120) to lower than 10. The white blood cell count was not elevated. In none of the cases radiological signs of loosening was found and the mean HHS was 88 (75–96) points. However in 3 patients the infection did re-occur: once after 2.5 months with the same bacterium as the first infection, a Streptococcus, again treated with a surgical debridement. At present she is clinical free of infection at a follow up of 2 years. The 2 other re-infections occurred respectively after 9 and 10 months, once after a surgical treatment of a jaw abscess and once after an episode of diverticulitis. The cultures derived other bacteria, a streptococcus and an E. coli, than the first infection, both a Staphylococcus aureus. In both cases a two-stage revision was the choice of treatment.