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BP reports grants from Stryker, outside the submitted work. PM reports personal fees from Global Research Solutions outside the submitted work. PTIII reports other from Smith & Nephew and other from Lippincott Williams & Wilkins outside the submitted work. SS reports grants from the Canadian Institutes of Health Research, employment/salary from McMaster University, and employment/salary from Global Research Solutions outside the submitted work. All procedures followed were in accordance with ethical standards of the ethics boards. Informed consent was obtained from all participants prior to enrollment.
#GAJEWSKI ADAM JOHN TRIAL#
REB Approval for the FLOW pilot and definitive trial was obtained at the coordinating centre (McMaster University) (REB: 05–299 and 08–268) and at each clinical site. NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.įLOW trial Large trials Orthopaedic trial Sample size.Įthics approval and consent to participate Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50-1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04-1.57). The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75-3.04 RR: 1.39, 95% CI: 0.60-3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81-1.33).
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At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study.
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To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data.