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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