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what's the sample of An internal pilot study was conducted in June 2016 to assess feasibility and safety of the intervention and for sample size
what's the sample of An internal pilot study was conducted in June 2016 to assess feasibility and safety of the intervention and for sample size calculation. Based on the pilot study, where 60% of the patients in the intervention group were free from infections at four weeks compared to 42% in the control group, a total of 82 samples were required with 90% power and a non-inferiority margin of 10% with an assumed dropout rate of 10%. Consecutive sampling technique was used to enroll all the participants who met the inclusion criteria. Patients were randomly allocated to control and intervention group via computer-generated random table. Patients and microbiologists assessing the swab cultures and blood cultures were masked to group assignment. The primary analysis was intention-to-treat (ITT). Data were coded and entered in SPSS (Statistical Package for Social Sciences) version 20. Descriptive statistics (percentage, mean, standard deviation, and Chi-square) and inferential statistics (t-test) were used to analyze data. Chi-square test was used to calculate the primary outcome. Data access and submission responsibility were limited to study authors only. P value < 0.05 was considered significant
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