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Catheter securement systems: comparison of two investigational devices to a sutureless securement device, a securement dressing, and sutures in a pig model.

Rutledge LF, DeCabooter DP, Walters SA, Bernatchez SF - Intensive Care Med Exp (2015)

Bottom Line: Comparison analysis was carried out using a mixed effects model with pig, sample, and sample location as factors.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 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.

View Article: PubMed Central - PubMed

Affiliation: Critical & Chronic Care Solutions Division, 3M Company, 3M Center Bldg 270-3A-04, St. Paul, MN, 55144-1000, USA, lfrutledge1@mmm.com.

ABSTRACT

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.

No MeSH data available.


Application of the investigational materials. a Securement device. b Securement dressing. c Sutures. d Investigational devices 1 and 2. For each device, the first photo shows the fixation device itself, and the second photo shows the final result after the device is covered with the appropriate dressing. For the investigational devices, the first photo shows the fixation device itself, the second photo shows it covered with the dressing without the CHG pad, and the third photo shows the fixation device covered with the CHG dressing
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Fig2: Application of the investigational materials. a Securement device. b Securement dressing. c Sutures. d Investigational devices 1 and 2. For each device, the first photo shows the fixation device itself, and the second photo shows the final result after the device is covered with the appropriate dressing. For the investigational devices, the first photo shows the fixation device itself, the second photo shows it covered with the dressing without the CHG pad, and the third photo shows the fixation device covered with the CHG dressing

Mentions: Figure 2 provides illustrations of the various devices and how they were applied, as modeled on a flat surface for better photographic results. For each device, the first photograph shows the fixation device itself and the second photograph illustrates the device covered with the appropriate dressing. Each device that was not a dressing was covered to comply with its instructions for use to ensure the most clinically relevant test result. For the investigational devices, the first photo shows the fixation device itself, the second photo shows it covered with the dressing without the CHG pad, and the third photo shows the fixation device covered with the CHG dressing.Fig. 2


Catheter securement systems: comparison of two investigational devices to a sutureless securement device, a securement dressing, and sutures in a pig model.

Rutledge LF, DeCabooter DP, Walters SA, Bernatchez SF - Intensive Care Med Exp (2015)

Application of the investigational materials. a Securement device. b Securement dressing. c Sutures. d Investigational devices 1 and 2. For each device, the first photo shows the fixation device itself, and the second photo shows the final result after the device is covered with the appropriate dressing. For the investigational devices, the first photo shows the fixation device itself, the second photo shows it covered with the dressing without the CHG pad, and the third photo shows the fixation device covered with the CHG dressing
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4549365&req=5

Fig2: Application of the investigational materials. a Securement device. b Securement dressing. c Sutures. d Investigational devices 1 and 2. For each device, the first photo shows the fixation device itself, and the second photo shows the final result after the device is covered with the appropriate dressing. For the investigational devices, the first photo shows the fixation device itself, the second photo shows it covered with the dressing without the CHG pad, and the third photo shows the fixation device covered with the CHG dressing
Mentions: Figure 2 provides illustrations of the various devices and how they were applied, as modeled on a flat surface for better photographic results. For each device, the first photograph shows the fixation device itself and the second photograph illustrates the device covered with the appropriate dressing. Each device that was not a dressing was covered to comply with its instructions for use to ensure the most clinically relevant test result. For the investigational devices, the first photo shows the fixation device itself, the second photo shows it covered with the dressing without the CHG pad, and the third photo shows the fixation device covered with the CHG dressing.Fig. 2

Bottom Line: Comparison analysis was carried out using a mixed effects model with pig, sample, and sample location as factors.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 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.

View Article: PubMed Central - PubMed

Affiliation: Critical & Chronic Care Solutions Division, 3M Company, 3M Center Bldg 270-3A-04, St. Paul, MN, 55144-1000, USA, lfrutledge1@mmm.com.

ABSTRACT

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.

No MeSH data available.