Camstent Coated Foley Catheter
Research type
Research Study
Full title
Characterisation of biofilm growth on coated vs. uncoated urinary catheter surfaces in normal clinical use.
IRAS ID
242341
Contact name
Manjunath Prasad
Contact email
Sponsor organisation
South Tees Hospitals NHS FT
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Hospital Acquired Infections (HAI) cause significant patient complications. As much as 40% of all HAIs are associated with the use of urinary catheters, causing discomfort to patients (i.e. prostatitis, epididymitis, cystitis, septic arthritis, meningitis), prolonged hospital stays, and increases in costs of care and patient mortality, with more than 13,000 deaths associated with urinary tract infections each year.
Efforts have been made to address the problem through better staff training, minimising the duration of device use, and application of device coatings intended to kill the bacteria using antibiotic drugs or silver toxins. None have impacted infection rates.
Bacterial colonisation via biofilm growth is recognised as the basis for infection, so Camstent’s focus has been prevention of biofilm formation and subsequently, the bacterium that cause infection. This ‘bacteria-phobic’ effect of Camstent's coating has been demonstrated in laboratory experiments which now must be replicated in man.
The participants (n=35) are adult patients that will be undergoing routine catheterisation as part of their customary hospital care. 15 will receive standard uncoated catheters, and 20 the Camstent coated catheter. Both versions are approved for patient use, and standard hospital issue catheterisation protocols for patient selection and insertion/withdrawal will be followed.
The supplement to hospital protocol only occurs after withdrawal. Instead of disposing the catheter as medical waste, the catheters will be sent for biofilm analysis.
Enrollment is expected to take two months, depending on catheterisation rate. No additional risks to patients or staff are created by sending catheters for analysis after use.If successful, the study will demonstrate an effective method for reducing a major source of HAI, with potential to improve patient outcomes and decrease hospital care costs.
REC name
North East - York Research Ethics Committee
REC reference
18/NE/0246
Date of REC Opinion
14 Aug 2018
REC opinion
Favourable Opinion