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Catheter securement systems: comparison of two investigational devices to a sutureless securement device, a
Laura F Rutledge1, Daniel P DeCabooter, Shelley-Ann H Walters
1Critical & Chronic Care Solutions Division, 3M Company, 3M Center Bldg 270-3A-04, St. Paul, MN, 55144-1000, USA, lfrutledge1@mmm.com.
Background:
Catheter 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.
Methods:
Twenty-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.
Results:
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. 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).
Conclusion:
The 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.
