Study Shows Effectiveness of ChloraPrep in SSI Prevention

Data published today in the New England Journal of Medicine demonstrates that use of CareFusion’s patient preoperative skin preparation ChloraPrep® (2 percent chlorhexidine gluconate and 70 percent isopropyl alcohol) reduced total surgical site infections (SSIs) by 41 percent, from 16.1 percent to 9.5 percent, compared to use of povidone-iodine solution, the most commonly used preoperative skin preparation.

In this prospective, randomized and well-controlled outcomes trial designed to compare the efficacy of skin antiseptics in reducing the risk of SSIs, ChloraPrep proved superior in clean-contaminated abdominal, urologic, gynecologic and thoracic surgery.

 “For nearly a decade, healthcare professionals have relied on the proven efficacy of ChloraPrep,” said Stephen R. Lewis, MD, chief medical officer of CareFusion. “This study is an example of our ongoing commitment to providing clinicians with evidence-based data that clinically differentiates our products in order to help improve patient care and lower costs.”

SSIs are one of the most common types of health care-associated infections (HAIs); 1.7 million people suffer HAIs each year, resulting in approximately 271 deaths per day. Approximately 300,000 to 500,000 Americans develop SSIs each year, resulting in an annual cost of approximately $7.4 billion. The issue is not limited to the U.S. In the United Kingdom, one in twenty (five percent) patients undergoing surgery is at risk of developing an infection and SSIs account for one-third of all deaths following surgery.

SSIs can occur when microorganisms naturally found on the skin of a patient enter the body when the skin’s protective barrier is compromised during the surgical procedure. There are many guidelines that suggest critical steps health care facilities can take to reduce the risk of surgical site infection, yet despite these recommendations SSIs continue to represent a significant and costly problem for the health care system.

 Furthermore, the problem of SSIs is often the center of discussion on third-party payment policies. For example, in October 2008 the Centers for Medicare & Medicaid Services (CMS) stopped reimbursing for treatment of select health care-acquired conditions, including certain SSIs. According to CMS, certain SSIs “can reasonably be prevented” with the use of evidence-based prevention guidelines that include use of patient preoperative skin preparations and good clinical practices. This change in policy has necessitated that health care facilities focus more than ever on reducing the risk of HAIs, not just because of the human costs, but because of the financial costs.

 The effectiveness of ChloraPrep may be attributed to its more rapid and persistent action against microorganisms. Unlike ChloraPrep, povidone-iodine can be neutralized by blood and other organic matter, reducing its effectiveness and persistence. The residual effect of ChloraPrep allows for added clinical benefit when used as a preoperative skin preparation. In fact, the efficacy and safety of ChloraPrep for skin antisepsis are supported by more than 35 clinical studies and recommendations by 18 internationally recognized organizations or guidelines, including 11 that specifically recommend 2 percent chlorhexidine – a key ingredient in ChloraPrep.

 This prospective, randomized, multicenter, well-controlled outcomes clinical trial enrolled 897 patients at six hospitals in the United States; 849 patients were included in the analysis. Patients in the two groups were similar with respect to multiple factors, including demographics, other medical conditions, individual risk for infection, and both the length and type of surgery.

The independent study was made possible through a research and educational grant from CareFusion.