Abstract
BackgroundCatheter securement is critical for the success of infusion therapy and to prevent complications. Our purpose was to compare the strength of catheter securement achieved with two investigational adhesive securement devices to two securement products and also to sutures using an in vivo animal model.MethodsTwenty-five live pigs were prepared for aseptic abdominal surgery. Four central venous catheters were inserted per animal into the epigastric veins and secured with four of the five securement systems studied, following a balanced incomplete randomized block design. A peak axial pull force test method was used to measure the force required to dislodge the catheter 1 cm from the insertion site and/or cause failure of the device and/or dressing. This pull test was done 10 min after device application, per constraints of the animal model. Comparison analysis was carried out using a mixed effects model with pig, sample, and sample location as factors. Non-inferiority testing was carried out using 95 % confidence intervals with a margin of 4.52 N or 1 lb (454 g). Tukey’s method was used to adjust for multiple pairwise comparisons.ResultsResults showed that the two investigational devices displayed the highest mean peak axial pull forces (40–41 N) and were significantly better than sutures (28 N, p < 0.0001) and the securement dressing (17 N, p < 0.0001) and non-inferior to the securement device (37 N) in this test. The securement device required a higher mean peak axial pull force than sutures (p = 0.0007) and the securement dressing (p < 0.0001) for failure to occur. Finally, there was also a statistical difference between sutures and the securement dressing, with sutures requiring a higher mean peak axial pull force for catheter dislodgement than the securement dressing (p < 0.0001).ConclusionThe two investigational devices appear to be a promising alternative for catheter securement, superior to sutures and the securement dressing, and non-inferior to the securement device.
Highlights
Catheter securement is critical for the success of infusion therapy and to prevent complications
Results showed that the two investigational devices displayed the highest mean peak axial pull forces (40–41 N) and were significantly better than sutures (28 N, p < 0.0001) and the securement dressing (17 N, p < 0.0001) and non-inferior to the securement device (37 N) in this test (Fig. 5)
Our results showed that the two investigational devices displayed the highest mean peak axial pull forces (40–41 N) and were significantly better than sutures (28 N, p < 0.0001) and the securement dressing (17 N, p < 0.0001) and non-inferior to the securement device (37 N) in this test
Summary
Catheter securement is critical for the success of infusion therapy and to prevent complications. The use of sutures is associated with needlestick or sharp injuries to the health-care worker, as well as patient discomfort and the consequences related to disrupting the patient’s skin barrier [7]. To address these issues, manufactured catheter stabilization devices have entered the market in the last decade and are gaining in acceptance to provide securement [8]. Changing practice in health care can take a long time and physicians are likely to continue using sutures for securing CVCs until a larger body of evidence exists for an effective alternative
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