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. 2020 Apr 7;3(4):e202215. doi: 10.1001/jamanetworkopen.2020.2215

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.

a

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.