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Table 2 Study outcomes (n = 48)

From: Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial

 

Standard Care

ISD

TA

SSD

Total

Group size

11 (23%)

12 (25%)

12 (25%)

13 (27%)

48 (100%)

CVAD failure

 Failure

0 (0%)

2 (17%)a

0 (0%)

1 (8%)b

3 (6%)

 Catheter-days

162

139

148

224

673

 Incidence Rate

0.00 (^)

14.4

0.00 (^)

4.46

4.46

 (95% CI)

 

(3.61–57.7)

 

(0.63–31.7)

(1.44–13.8)

 Log-rank test p-values

referent

0.147

^

0.358

0.280

CVAD complications

 All-cause complicationsc

0 (0%)

1 (8%)

0 (0%)

2 (15%)

3 (6%)

 Incidence Rate

0.00 (^)

7.21

0.00 (^)

8.92

4.46

 (95% CI)

 

(1.02–51.2)

 

(2.23–35.7)

(1.44–13.8)

 Log-rank test p-values

referent

0.294

^

0.358

0.600

 Complicationc, d:

  CABSI

0 (0%)

0 (0%)

0 (0%)

1 (8%)

1 (2%)

  dislodgement (partial)

0 (0%)

1 (9%)

0 (0%)

1 (8%)

2 (4%)

  occlusion (complete)

0 (0%)

0 (0%)

0 (0%)

1 (8%)

1 (2%)

 All-cause skin complication d, e

2 (18%)

2 (17%)

0 (0%)

1 (8%)

5 (10%)

 Skin complication d, e:

  rash

1 (9%)

0 (0%)

0 (0%)

1 (8%)

2 (4%)

  blister

1 (9%)

1 (8%)

0 (0%)

0 (0%)

2 (4%)

  itchiness

2 (18%)

1 (8%)

0 (0%)

0 (0%)

3 (6%)

 Staff satisfaction f, g

  on application

8.8 (1.6)

7.9 (2.0)

7.9 (2.1)

7.4 (1.7)

8.0 (1.9)

  on removal

8.9 (1.6)

8.6 (1.6)

5.5 (2.8)

8.2 (1.6)

7.8 (2.4)

 Parent satisfaction on removal f, g

5.3 (2.3)

9.2 (1.0)

8.0 (1.7)

8.5 (1.9)

7.8 (2.3)

  1. n (%) shown unless otherwise noted
  2. CABSI Catheter associated bloodstream infection, CVAD Central venous access device, CI confidence interval, ISD Integrated securement dressing, TA Tissue adhesive, SSD Suture-less securement device
  3. ^ = cannot be calculated
  4. a due to spontaneous internal displacement; partial dislodgement
  5. b due to partial dislodgement and occlusion
  6. c at study completion
  7. d Participants could have more than one complication or skin complication
  8. e during the study period
  9. f measured on a 0 (minimum) to 10 (maximum) scale
  10. g mean and standard deviation