| 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) | Â |
Dwell time (device-days) | 362 | 430 | Â |
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) | Â |
Treatment incomplete with complications | 37 (25) | 39 (26) | Â |
Treatment complete without complications | 92 (61) | 86 (57) | Â |
Insertion of a CVAD | 2 (1) | 4 (3) | Â |
Deceased | 1 (1) | 3 (2) | Â |
Other | 3 (2) | 2 (1) | Â |
Routine resite | 5 (3) | 9 (6) | Â |
Admission to ICU | 1 (1) | 2 (1) | Â |
Complication at removal: | |||
Occlusion, infiltration, extravasation, leakage | 32 (21) | 30 (20) | Â |
Phlebitis, too painful to tolerate | 9 (6) | 8 (5) | Â |
Partial dislodgement, accidental removal | 6 (4) | 6 (4) | Â |
Other | 4 (3) | 5 (3) | Â |
Serious adverse events: | |||
Death | 2 (1) | 4 (3) | Â |
Positive blood culture | 1 (1) | 4 (3) | Â |
ICU admission | 1 (1) | 2 (1) | Â |
Phlebitis signs or symptomsd (n = 163): | |||
Pain or tenderness ≥2 out of 10 | 3 (4) | 5 (6) |  |
Erythema >0.5Â cm | 3 (4) | 0 (0) | Â |
Swelling >0.5Â cm | 4 (5) | 5 (6) | Â |
Hardness >2Â cm | 3 (4) | 2 (2) | Â |
Palpable cord | 0 (0) | 0 (0) | Â |
Vein streak >1Â cm | 1 (0) | 0 (0) | Â |
Purulence | 0 (0) | 0 (0) | Â |
Number of dressings usede | 156 (1.04) | 152 (1.01) | Â |
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 | Â |
Bleeding | 2 | 0 | Â |
Unknown | 1 | 0 | Â |
Protocol deviations: bordered polyurethane dressing | 0 | 2 | Â |
Additional securement devices:g | |||
Elasticised tubular bandage | 22% | 28% | Â |
Non-sterile tape | 11% | 15% | Â |
Bandage | 4% | 0% | Â |
Simple transparent dressing | 2% | 0% | Â |
Fabric fixation tape | 1% | 0% | Â |
Clean, dry and intactg | 66% | 83% | Â |
Appearance of dressing:g | |||
Lifting slightly on the edges | 12% | 4% | Â |
Dried blood at insertion site | 3% | 5% | Â |
Lifting a great deal | 4% | 1% | Â |
Blood leaking from the site | 3% | 1% | Â |
Other | 1% | 0% | Â |
Patient satisfaction (0 = worst, 10 = best; n = 157)f | 9.0 (8.0–10.0) | 9.0 (8.0–10.0) |  |