
Trauma
OTA 2016: A pilot RCT evaluating trial feasibility for open tibial fractures in Tanzania
40 patients with open tibial fractures were included in this pilot study to evaluate the feasibility of a large randomized trial investigating the incidence of surgical site infection with different fixation methods. Patients were randomized to fixation using an intramedullary nail or an external fixator, and incidence of superficial surgical site infections was evaluated at 2-week follow-up. The results of this pilot study indicate that a larger trial is feasible, as 40 of 95 patients screened over a 2 month period met inclusion criteria, all of whom consented to study participation. A high follow-up rate was also achieved, with 39 patients available for follow-up at 2 weeks. There was no significant difference in the incidence of superficial surgical site infection between the two methods of fixation. A large-scale trial will now be conducted based on the feasibility result of this trial.
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