Abstract
BACKGROUND: Totally implantable venous access ports (TIVAPs) are essential for administering chemotherapeutic drugs and nutritional support, but carry a risk of infectious complications. We hypothesized that the design of the current port needle (Huber) could facilitate the collection of bacteria from the skin during puncture, potentially introducing them into TIVAPs and causing infections. This study examines bacterial transfer via needles during TIVAP access and proposes a novel needle design to reduce the risk of infection. METHODS: A novel needle, the Forsvall Port needle, was developed with a closed tip to reduce bacterial transmission inside the needle during tissue and port penetration. In a randomized ex vivo setting, human skin samples covered in physiological levels of Staphylococcus aureus were placed over port membranes and punctured repeatedly by the standard Huber needle and the Forsvall Port needle. Cultures from the needle tips were plated after puncture and used to compare bacterial transfer into TIVAPs using a generalized linear mixed-effects model. Punctures were performed in a separate human skin to examine the mechanism of bacterial transfer. RESULTS: The Forsvall Port needle reduced average bacterial transfer by 87.0% (95% CI: 77.8%-92.4%, p < 0.0001) compared with the Huber needle, based on 10 punctures per needle across four skin samples. Additional testing on a separate skin sample showed that a defectively fitted Forsvall Port needle prototype did not reduce bacterial transfer relative to the Huber needle (95% CI: 58.3% decrease to 30.0% increase, p = 0.289), whereas a steel rod simulating a perfectly closed Forsvall Port needle achieved a 99.9% (95% CI: 99.5%-100%, p < 0.0001) reduction in bacterial transfer. CONCLUSION: The Forsvall Port needle significantly reduces bacterial transfer into TIVAPs, which could potentially decrease TIVAP-related infections. This study demonstrates a strong association between needle design and bacterial transfer during TIVAP access.