Complications of peripherally inserted central catheters in adult hospitalized patients and outpatients in the KTFIXPICC study: A randomized controlled trial evaluating a fixation device KT FIX Plussystem

Published:December 28, 2021DOI:


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        No statistically differences for complications between dressing devices
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        Specific increased risk of infection for BMI ≥ 30 kg/m2 and diabetes mellitus.
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        Specific increased risk of thrombosis for chronic renal failure and malignancy.
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        Less catheter migration and accidental withdrawal in outpatients.
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        More accidental withdrawal and occlusion with multiple lumen catheters.


      Poor securement potentiates Peripherally inserted central catheters (PICC) complications. A dressing device (KT FIX Plus) offers stronger skin attachment, which may reduce the risk of dressing disruption. We aimed to evaluate this device.


      We conducted a single-center parallel-group open-label randomized controlled trial. Hospitalized and outpatient consecutive adults requiring PICCs were randomized to KT FIX Plus or standard of care (SOC). The primary endpoint was the composite of PICC-associated complications until removal, including occlusion, migration, accidental withdrawal, infection, thrombosis, and hematoma.


      No statistically significant difference was observed in terms of complications: 67 (35%) in the KT FIX Plus group vs 36 (37%) in the SOC group (log-rank P = 0.76). In multivariate Cox analysis, independent risk factors for PICC-associated complications were obesity (adjusted hazard ratio (aHR), 1.08, P < .001) and diabetes (aHR, 1.85, P = .039), adjusting for chronic renal failure, number of lumens, catheter/vein diameter ratio and duration of home-based care. Multiple lumen catheters increased the risk of accidental withdrawal and migration (HR, 2.4, P = .008).


      In our study, the use of KT FIX Plus did not reduce the risk of complications adjusting for other risk factors such as obesity and diabetes. The number of catheter lumens is one of the modifiable factors to reduce complications. Further studies are required to find the best securement and dressing system.

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