CDC reviews clinical data from patients treated with BIOPATCH Protective Disk with CHG

Apr 2 2011

Ethicon, Inc., announced today that the CDC has reviewed clinical data from patients treated with BIOPATCH® Protective Disk with CHG as part of its update to the 2002 guidelines for reducing risk of intravascular catheter-associated infections in the United States. In the new guidelines, use of a CHG sponge dressing is designated as a Category 1B recommendation. BIOPATCH® is the only CHG-impregnated sponge dressing clinically proven to reduce central line-associated bloodstream infections (CLABSIs) and the only CHG-impregnated product with an FDA-cleared indication for this use.

The CDC's 2011 Guidelines for the Prevention of Intravascular Catheter-Related Infections defines a recommendation classified as Category 1B as "strongly recommended for implementation and supported by some experimental, clinical, or epidemiologic studies and a strong theoretical rationale." BIOPATCH® Protective Disk with CHG, distributed by Ethicon, Inc., has been shown to reduce the risk of CLABSIs in controlled, randomized clinical trials involving more than 4,000 patients.

"The new guidelines reinforce the findings from multiple clinical studies that have shown that BIOPATCH® is proven safe and effective in reducing the risk of CRBSIs in patients with central venous or arterial catheters. No other CHG dressing product on the market has been clinically proven to reduce this risk, and we are very pleased that the Category 1B recommendation has been based on clinical evidence related only to BIOPATCH®," said Earl Adamy, director of BIOPATCH®  sales and marketing at Ethicon.

The guidelines indicate that patients should be treated with "a chlorhexidine-impregnated sponge dressing for temporary short-term catheters in patients older than 2 months of age, if the CLABSI rate is not decreasing despite adherence to basic prevention measures, including education and training, appropriate use of chlorhexidine for skin antisepsis, and MSB [maximal sterile barrier precautions]. Category IB." Guidelines also specify "no recommendation is made for other types of chlorhexidine dressings (Unresolved Issue)."

In the United States, approximately 250,000 CLABSIs are estimated to occur each year. CLABSIs are associated with high mortality rates (12-25%), and extended hospital stays, requiring patients to spend an estimated 9-12 additional days in a hospital. According to the CDC, the cost of treating a single episode of CLABSI can range from $34,508 - $56,000. The average cost of the BIOPATCH® Protective Disk with CHG product is approximately $6.

"Our skin provides very effective protection against infection, but when the skin barrier is broken and a catheter is inserted into vascular tissue, the risk of bacteria migrating down the catheter itself or the catheter tract into the bloodstream increases significantly. BIOPATCH® has a unique proprietary design that allows for 360-degree contact with the skin and continuous delivery of CHG around the site of catheter insertion," said William Jarvis, MD, former acting director of the CDC's Hospital Infections Program and the former assistant chief of the National Nosocomial Infections Surveillance (NNIS) system.

The safety and effectiveness of BIOPATCH® have not been established for children less than 16 years of age. The protective disk is not to be used on premature infants or on patients with a known sensitivity to CHG.