Table 3. Sample Size Estimates.
Iodine risk ratio | Iodine odds ratio | Sample size | Sample size increased by 10% |
---|---|---|---|
Aqueous-PREP and the PREPARE open fracture cohorta | |||
10.0% Baseline SSI risk | |||
0.62 | 0.59 | 1600 | 1760 |
0.65 | 0.63 | 1960 | 2100 |
0.67 | 0.65 | 2200 | 2420 |
0.70 | 0.68 | 2600 | 2860 |
12.5% Baseline SSI risk | |||
0.62 | 0.59 | 1300 | 1440 |
0.65 | 0.62 | 1400 | 1540 |
0.67 | 0.64 | 1600 | 1760 |
0.70 | 0.67 | 1800 | 1980 |
14.0% Baseline SSI risk | |||
0.62 | 0.58 | 1200 | 1320 |
0.65 | 0.61 | 1300 | 1440 |
0.67 | 0.64 | 1500 | 1660 |
0.70 | 0.67 | 1800 | 1980 |
PREPARE closed fracture cohorta | |||
2.0% Baseline SSI risk | |||
0.62 | 0.62 | 8200 | 9020 |
0.65 | 0.65 | 10 000 | 11 000 |
0.67 | 0.67 | 11 400 | 12 540 |
3.5% Baseline SSI risk | |||
0.62 | 0.61 | 4700 | 5170 |
0.65 | 0.64 | 5700 | 6280 |
0.67 | 0.66 | 6600 | 7260 |
5.0% Baseline SSI risk | |||
0.62 | 0.61 | 3300 | 3640 |
0.65 | 0.64 | 4100 | 4520 |
0.67 | 0.67 | 4300 | 4740 |
Abbreviations: Aqueous-PREP, Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous and Antiseptic Skin Solution in Open Fractures; PREPARE, Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities; SSI, surgical site infection.
Initial assumptions for sample size estimates: between-cluster intraclass correlation coefficient = 0.028; between-cluster variance = 0.095; between-period variance = 0; 10 clusters; 2 periods; α = .05.