Objective . A clinical investigation into a new bone void filler is giving
first data on systemic and local exposure to the anti-infective
substance after implantation. Method . A total of 20 patients with post-traumatic/post-operative bone
infections were enrolled in this open-label, prospective study.
After radical surgical debridement, the bone cavity was filled with
this material. The 21-day hospitalisation phase included determination
of gentamicin concentrations in plasma, urine and wound exudate, assessment
of wound healing, infection parameters, implant resorption, laboratory
parameters, and adverse event monitoring. The follow-up period was
six months. . Results . Systemic exposure to gentamicin after implantation was very low
as local gentamicin concentrations were measured in wound exudate
after six to ten hours. There were no signs of infectious complication
throughout the clinical phase. Four patients had recurrent infections
several weeks to months after implantation. The outcome was deemed successful
by remission of infection in 16 (80%) of these problematic long-term
treated patients. Safety laboratory measurements did not indicate
nephrotoxic or hepatotoxic effects. . Conclusions . Local application of calcium sulphate/carbonate bone void filler
comprising gentamicin revealed sufficient active local levels of
the antibiotic by simultaneous significant low systemic exposure
in patients with mostly
