A characterisation of biofilm load on a Camstent’s coated Foley catheter

A North East and North Cumbria Innovation Pathway partnership case study

Camstent was introduced to MedConnect North in August 2017, with the aim of providing good quality clinical data surrounding their innovative catheter coating.

NICE reports that 6.4% of people admitted to hospital get an infection; it’s estimated that up to 38% of all Hospital Acquired Infections (HAIs) are caused by urinary catheters (http://camstent.com/problem-hospital-acquired-infection). Camstent viewed coating catheters as a way of decreasing the catheter associated infections and developed an approved coating that resists bacterial attachment in laboratory tests. If this can be demonstrated in clinical settings, it may in turn lower the rate of catheter related HAIs.

The team identified Mr Prasad of The James Cook University Hospital as a potential lead due to the patient population being ideal for the pilot study. Initial conversations with Mr Prasad focused on the results from the lab trial, appropriate patient population for the research trial and how best to set up the pilot study while looking towards how the results may be used to progress onto a larger clinical trial with potential funding streams.

Camstent and Mr Prasad worked together to develop a robust protocol which would not only help to provide evidence on the coated catheters but would also be fit to run within South Tees Hospital. South Tees Research and Development and the Clinical Research Network North East and North Cumbria also assisted in supporting the study team in the completion of the regulatory applications and supporting documents for the trial (patient information sheets and consent forms).

The discussions resulted in the Camstent Foley Catheter trial. This pilot study is currently in set up at James Cook University Hospital (South Tees Hospitals NHS Foundation Trust) and is looking to recruit 20 participants to trial the new catheter and send the results to Nottingham University Laboratories for review. The aim of the trial is to validate the claims that a bacteria resistant coating reduces HAIs and provides better outcomes when compared against standard of care catheters.

The Camstent Foley Catheter trial demonstrates collaborative working between The James Cook University Hospital, MedConnect North, NIHR Clinical Research Network North East and North Cumbria and Camstent in setting up a study to collect evidence for a new device to assist patients in receiving high quality care and address infection issues in the NHS.