Septocoll® E - Biomet

Septocoll ® E – Clinical StudiesSeptocoll E is the enhanced version of the establishedproduct Septocoll. Both products have the same pharmacokineticprofile and identical specifications as regards theirgentamicin content. The only difference is their collagencontent and the origin of this collagen.Biological Resorption StudiesComprehensive tests were carried out to examine thebiocompatibility of Septocoll E. All the studies wereperformed at independent, accredited institutes inaccordance with the specifications of the German MedicalDevices Act (MPG) and in compliance with ISO 10993.• Cytotoxicity test• Mouse lymphoma assay• Magnusson/Kligman sensitization test• Systemic toxicity• Short-term implant – 4 weeks• Long-term implant – 12 weeks• Carcinogenicity test on gentamicin crobefateThese tests confirmed unreservedly the biocompatibilityof Septocoll E. In particular, no allergic reactions wereobserved. No implant remains were detected four weeksafter insertion of the fleece.Pharmacokinetic Studies (11)Study to evaluate the pharmacokinetic behavior afterimplantation of Septocoll or a collagen fleece loaded onlywith gentamicin sulfate in patients with bone infections.DesignProspective, randomized, single-blind study with parallelgroups.Patient Population40 patients: 20 in the Septocoll group,20 in the sulfate fleece groupTreatments and DosagesSeptocoll group: 2 fleeces Septocoll 40(equivalent to 140 mg gentamicinbase)Sulfate fleece group: 1 sulfate fleece(equivalent to 120 mg gentamicinbase)The values measured were adjusted accordingly(factor 0.8 =120 :140)8Results/Target Criteria/EndpointComparison of the pharmacokinetics of the two gentamicinloadedcollagen fleeces, control period: 10 daysThe pharmacokinetic behavior of Septocoll is superiorto that of sulfate fleeces: In the Septocoll group, higher,longer-lasting and more evenly distributed gentamicinconcentrations were found. In the Septocoll group, theurine and serum concentrations of gentamicin were lower.