The objective of the study was to determine if the use of locally implanted, synthetic calcium sulfate tablets, impregnated with antibiotics, can heal lower-extremity osteomyelitis, without the use of oral and/or intravenous antibiotics or wound complications associated with similarly used mined or refined calcium sulfate.
Over a 5-year period, 354 patients with clinically confirmed osteomyelitis of the lower extremity were evaluated, and 337 met the inclusion criteria; 14 were lost to follow-up.
Devitalized or infected bone was debrided to the level of healthy cancellous and cortical bone. Compromised soft tissue was resected. At the onset of each operative encounter, the synthetic calcium sulfate tablets were mixed with a standard antibiotic mixture: 500 mg of powdered vancomycin mixed into 240 mg of gentamicin (normally supplied as a liquid in a concentration of 80 mg/2 mL). Vancomycin and gentamicin were chosen because they cover a broad spectrum of both gram-positive and gram-negative bacteria.
A total of 279 of 323 patents (86.4%) clinically healed without the use of intravenous antibiotics following surgical debridement and tablet implantation. In addition, 24/323 (7.4%) required the use of intravenous antibiotics, but still healed; 20/323 (6.2%) required amputation, of which, 12 (3.7%) were digital amputations, 2 (0.6%) were ray amputations, and 6 (1.9%) were below-knee amputations.
The use of locally implanted antibiotic-impregnated, synthetic calcium sulfate tablets in the surgical debridement site for bone infections of the lower extremity, without the concurrent use of intravenous antibiotics, has shown encouraging results.