Pivotal study could establish new standard of care for preventing surgical-site infections
HOUSTON - Patients, whose surgeons use chlorhexidine-alcohol rather than povidone-iodine to cleanse their skin before surgery, are approximately 40 percent less likely to experience surgical-site infections.
In a study published in the The New England Journal of Medicine, researchers from four Department of Veterans Affairs medical centers and two non-VA hospitals found preoperative cleansing of patients’ skin with chlorhexidine-alcohol is superior to cleansing with povidone-iodine for preventing surgical-site infection.
"The overall rate of surgical-site infection using chlorhexidine-alcohol (a green-blue color) was 9.5 percent, compared to 16.1 percent with povidone-iodine (a reddish color). These findings indicate only 17 patients need to receive an optimal skin antiseptic preparation in order to prevent one infection,” said Rabih O. Darouiche, M.D., principal author of the paper, staff physician at the Michael E. DeBakey VA Medical Center in Houston, and VA Distinguished Service Professor of Medicine and Physical Medicine & Rehabilitation at Baylor College of Medicine. “The results of this study are extremely significant since two-thirds of surgical-site infections are confined to the incision."
A clinical trial involving 847 evaluable patients was conducted between April 2004 and May 2008 at the Michael E. DeBakey VA Medical Center, Houston; the VA Boston Healthcare System; the Milwaukee VA Medical Center; the Atlanta VA Medical Center; the Medical College of Wisconsin, Milwaukee; and Ben Taub General Hospital, Houston.
Approximately 27 million operations are performed each year in the United States. Despite the implementation of preoperative preventive measures, which include skin cleansing with povidone-iodine (the current standard of care practice for surgical site-antisepsis), surgical-site infection occurs in 300,000 to 500,000 surgery patients each year in the United States.
The Centers for Disease Control and Prevention has recommended the use of chlorhexidine-based preparations, but it has not made a recommendation as to the type of antiseptics that should be used for pre-operative prevention of surgical-site infection.
The two antiseptics studied are manufactured by CareFusion, a company formed by Cardinal Health, which funded the research. One author is from Cardinal Health and substantially contributed to the design and conception of the study and critically revised the manuscript. However, this author played no role in data collection or analysis.
For more than 30 years, VA has been a leader in conducting comparative effectiveness research (CER) — head-to-head studies that help clarify which among two or more health interventions works better for a given health condition in certain patients. Some of these trials compare one drug to another, while others compare different approaches such as surgery versus an accepted drug therapy, or different ways to deliver care to patients. By comparing drugs and/or other medical approaches, VA’s CER is providing evidence-based information that can be used in shared decision-making by health professionals and their patients.
As the largest research program embedded in an integrated health care system in the United States, and possibly the world, VA conducts cooperative research studies across a continuum – from biomedical and rehabilitation research to clinical trials, health services research, and quality improvement and implementation research