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Table 2 Device and other outcomes, including time-to-event analysis (n = 300)

From: A novel integrated dressing to secure peripheral intravenous catheters in an adult acute hospital: a pilot randomised controlled trial

 

Control

Intervention

p value

Primary outcome: device failure

43 (29)

40 (27)

0.699a

Dwell time (hours)b

57.9 (40.5)

68.8 (50.7)

 

Dwell time (device-days)

362

430

 

Incidence rate (95% CI, per 1000 device-days)

119 (88–160)

93 (68–127)

 

Incidence rate ratio (95% CI)

Referent

0.78 (0.50–1.23)

0.137c

Why was the device removed?

Treatment complete with complications

9 (6)

5 (3)

 

Treatment incomplete with complications

37 (25)

39 (26)

 

Treatment complete without complications

92 (61)

86 (57)

 

Insertion of a CVAD

2 (1)

4 (3)

 

Deceased

1 (1)

3 (2)

 

Other

3 (2)

2 (1)

 

Routine resite

5 (3)

9 (6)

 

Admission to ICU

1 (1)

2 (1)

 

Complication at removal:

Occlusion, infiltration, extravasation, leakage

32 (21)

30 (20)

 

Phlebitis, too painful to tolerate

9 (6)

8 (5)

 

Partial dislodgement, accidental removal

6 (4)

6 (4)

 

Other

4 (3)

5 (3)

 

Serious adverse events:

Death

2 (1)

4 (3)

 

Positive blood culture

1 (1)

4 (3)

 

ICU admission

1 (1)

2 (1)

 

Phlebitis signs or symptomsd (n = 163):

Pain or tenderness ≥2 out of 10

3 (4)

5 (6)

 

Erythema >0.5 cm

3 (4)

0 (0)

 

Swelling >0.5 cm

4 (5)

5 (6)

 

Hardness >2 cm

3 (4)

2 (2)

 

Palpable cord

0 (0)

0 (0)

 

Vein streak >1 cm

1 (0)

0 (0)

 

Purulence

0 (0)

0 (0)

 

Number of dressings usede

156 (1.04)

152 (1.01)

 

Duration of first dressing (hours)

47.8 (27.1–73.3)

53.2 (28.8–94.0)

 

Reason for dressing change:

Dressing lifting

3

2

 

Bleeding

2

0

 

Unknown

1

0

 

Protocol deviations: bordered polyurethane dressing

0

2

 

Additional securement devices:g

Elasticised tubular bandage

22%

28%

 

Non-sterile tape

11%

15%

 

Bandage

4%

0%

 

Simple transparent dressing

2%

0%

 

Fabric fixation tape

1%

0%

 

Clean, dry and intactg

66%

83%

 

Appearance of dressing:g

Lifting slightly on the edges

12%

4%

 

Dried blood at insertion site

3%

5%

 

Lifting a great deal

4%

1%

 

Blood leaking from the site

3%

1%

 

Other

1%

0%

 

Patient satisfaction (0 = worst, 10 = best; n = 157)f

9.0 (8.0–10.0)

9.0 (8.0–10.0)

 
  1. Frequencies and column percentages shown, unless otherwise noted
  2. CI confidence interval, CVAD central venous access device, ICU intensive care unit
  3. aChi-squared test
  4. bMean and standard deviation
  5. cLog-rank test
  6. dWithin 24 h of device removal
  7. eNumber and average number
  8. fMedian and 25th–75th percentiles
  9. gProportion of observations
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Trials

ISSN: 1745-6215