In two open prospective studies, the efficacy and tolerance of ofloxacin in the prevention of infection in patients with open fractures (n = 58) and in the treatment of chronic post-traumatic osteomyelitis (n = 115) were examined. In the study with open fractures, bone and/or soft tissue infection occurred in only four cases (6.5%). During an observation period of at least 12 months, post-traumatic osteomyelitis was seen in two patients with III degree open fractures (9%), while in the groups with I degree and II degree open fractures no bone infection could be found. Therefore, the rate of post-traumatic osteomyelitis related to all patients was 3.3%. In the second study with 115 patients suffering from chronic post-traumatic osteomyelitis 141 different Gram-positive and Gram-negative pathogens were isolated. 73% were Gram-positive cocci with Staphylococcus aureus in more than 50% of the cases. An elimination rate of more than 90% was found in the Gram-positive and Gram-negative bacteria, leading to a clinical cure in 85% and a recurrence of infection in 5% of the cases. The tolerability of ofloxacin was excellent. No drug-related allergic reactions were observed. Diarrhoea and headache occurred in less than 2% of patients. With adequate surgical treatment, ofloxacin proved to be a useful antimicrobial agent in the prevention and therapy of bone infection.
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