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.


Journal

American journal of infection control
ISSN: 1527-3296
Titre abrégé: Am J Infect Control
Pays: United States
ID NLM: 8004854

Informations de publication

Date de publication:
08 2022
Historique:
received: 19 10 2021
revised: 21 12 2021
accepted: 21 12 2021
pubmed: 2 1 2022
medline: 3 8 2022
entrez: 1 1 2022
Statut: ppublish

Résumé

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.

Sections du résumé

BACKGROUND
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.
METHODS
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.
RESULTS
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).
CONCLUSIONS
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.

Identifiants

pubmed: 34973357
pii: S0196-6553(21)00859-2
doi: 10.1016/j.ajic.2021.12.014
pii:
doi:

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

916-921

Informations de copyright

Copyright © 2022 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Auteurs

Audrey Fohlen (A)

Urodigestive Imagery and Interventional Radiology Department, University Hospital of Caen, CEDEX, Caen, France. Electronic address: fohlen-a@chu-caen.fr.

Anais R Briant (AR)

CHU de Caen, Department of Biostatistics and Clinical Research, Université Caen Normandie, Caen, France.

Jean Jacques Dutheil (JJ)

CHU de Caen, Department of Biostatistics and Clinical Research, Université Caen Normandie, Caen, France.

Vincent Le Pennec (V)

Urodigestive Imagery and Interventional Radiology Department, University Hospital of Caen, CEDEX, Caen, France.

Jean-Pierre Pelage (JP)

Urodigestive Imagery and Interventional Radiology Department, University Hospital of Caen, CEDEX, Caen, France.

Jean-Jacques Parienti (JJ)

CHU de Caen, Department of Biostatistics and Clinical Research, Université Caen Normandie, Caen, France.

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