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Table 1 Baseline demographics and outcomes in the groups receiving noble metal coated catheter or uncoated control catheter

From: Foley catheter with noble metal alloy coating for preventing catheter-associated urinary tract infections: a large, multi-center clinical trial

 

BIP Foley

n = 750

Control

n = 250

p-value

Relative reduction (RR) (%)

Demographics and comorbidities

Age, mean (SD)

48 (15)

47 (15)

0.0908

NA

Weight, mean (SD)

65 (34)

69 (58)

0.27

NA

Height, mean (SD)

161 (11)

162 (9)

0.39

NA

Sex, female, n (%)

235 (31)

101 (40)

0.0106

NA

Diabetes mellitus

46 (6.1)

19 (7.6)

0.4

NA

Cancer

5 (0.7)

5 (2)

0.07

NA

Distribution of patients at each site and ward type

Site 1 General surgery and ICU

102 (14)

34 (14)

NA

NA

Site 2 Urology

6 (1)

2 (1)

NA

NA

Site 3 Urology

96 (13)

32 (13)

NA

NA

Site 4 Urology

228 (30)

76 (30)

NA

NA

Site 5 General surgery

234 (31)

78 (31)

NA

NA

Site 6 Urology

84 (11)

28 (11)

NA

NA

Total General surgery and ICU

336 (45)

112 (45)

NA

NA

Total Urology

414 (55)

138 (55)

NA

NA

CAUTI

CAUTI incidences (%) TOTAL

52 (6.9)

53 (21.2)

 < 0.001

67%

CAUTI/1000 catheter days TOTAL

6.5 (52/(7987 * 10−3))

20.8 (53/(2551 days * 10−3))

 < 0.001

69%

General surgery and ICU (site 1 and 5)

CAUTI/1000 catheter days

12.3 (32/(2612 * 10−3))

47.9 (37/(773 * 10−3))

 < 0.001

70%

Urology (site 2–4, 6)

CAUTI/1000 catheter days

3.7 (20/5375 * 10−3))

9.0 (16/(1778 * 10−3))

0.006

58%

Bacteriuria

Positive growth at inclusion TOTAL n (%)

30 (4)

16 (6.4)

0.11

NA

Positive growth TOTAL n (%)

209 (28)

161 (64)

 < 0.001

57%

Positive growth, ≥ 105 CFU/ml n (%)

89 (11.9)

67 (26.8)

 < 0.001

56%

Positive growth, < 105 ≥ 103, CFU/ml n (%)

66 (8.8)

53 (21.2)

 < 0.001

59%

Antibiotics, catheterization days, hospital

Antibiotics prophylaxis*, days/antibiotic treated study patient

8.2

8.5

0.54

No significant difference

Antibiotics prophylaxis, days/all study patients

4.7

5.0

0.47

No significant difference

Duration of catheterization, days

11.1

10.9

0.79

No significant difference

Duration of hospital admission, days

6.5

6.3

0.59

No significant difference

Adverse events

Total number of AE (%)

162 (21.6%)

121 (48.4%)

 < 0.001

55%

Total patients with at least one AE n,

112 (14.9%)

80 (32.0%)

 < 0.001

53%

  1. *Antibiotics were received for other reasons than catheterization