Initial results of the first in-man pilot study comparing coated catheters from Camstent Ltd. (Sharnbrook, UK) and uncoated catheters showed that the coating resulted in a marked reduction of biofilm formation and biomineralization. The results are encouraging for the battle against hospital-acquired infections (HAIs), 38% of which are caused by catheter-associated urinary tract infections, said Camstent in an announcement on March 15.
The study compared 10 Camstent coated catheters with 12 uncoated silicone catheters. To support the evidence, further tests will compare larger numbers of catheters, evaluate the performance of coated catheters over longer time periods and delve into more detailed microbiological investigations, said Camstent.
Camstent-coated catheters currently carry the CE mark for drainage of urine and enhanced lubricity. They are undergoing a Notified Body review to determine the bacteria-phobic claim.
The 22 coated and uncoated samples, obtained from patients catheterized for bladder management after urethral reconstructive surgery, were allocated non-randomly, said Camstent. Once removed they were analyzed by scientists at the Centre for Biomolecular Sciences & School of Life Sciences, and the School of Pharmacy at the University of Nottingham.
“The coating includes one of a family of molecules discovered by materials scientists at the University of Nottingham,” Dave Hampton, MD, founder and CEO of Camstent, told PlasticsToday, adding that a paper was published in Nature Biotechnology in 2012. “Camstent took exclusive license of the polymers for use in urological devices and we have since developed them further, adding materials to make a coating that adheres securely and flexibly to the catheter," said Hampton.
The coating is applied to the inner and outer surfaces of the catheter using a simple “dip/dry” process before sterilization, creating a safe, inert and long-lasting finish, explained Hampton.
Unlike other coatings that are designed to kill bacteria adhering to the surfaces, Nottingham’s passive non-stick molecule within Camstent’s coating aims to deter bacteria from attaching to the catheter surfaces at all. In addition to reducing the formation of biofilm, the coating is not based on antibiotics and, therefore, will not contribute to the creation of antibiotic-resistant organisms, or super bugs.
“While our catheter was approved for use in patients last year for its silky-smooth texture, this is the first time we have confirmed evidence that our coating acts equally well in preventing biofilm attachment in humans," said Hampton. “These initial results are being corroborated by over 60 cases, as we expand the number of settings taking part in trials. We are looking to grow the body of evidence to support these initial results and welcome anyone interested in conducting trials to contact us.”
The Camstent coated catheter is available in the European Union and other countries that recognize the CE mark. The company said that it intends to file an application with FDA and hopes to bring the coated catheter to the U.S. market within the next six months.