Clinicians need every infection-preventing trick they can possibly get, but the “tricks,” of course, need to be proven in studies and experience before they are touted. One such tool that seems to have proven its way is BIOPATCH,® a disk that so far seems effective in preventing catheter-related bloodstream infections (CRBSIs) and local infections.
The “disk” is a small dressing that is used for skin antisepsis. It looks deceptively simple, but actually releases chlorhexidine gluconate (CHG) continually over seven days. According to the manufacturer, Johnson & Johnson’s Ethicon Inc., the BIOPATCH is effective even in the presence of organic matter such blood, sera and proteins.
Several infection control and prevention experts applaud the BIOPATCH. One is William R. Jarvis, MD, president of Jason and Jarvis Associates. Jarvis has two infectious disease fellowships, worked for the Centers for Disease Control and Prevention (CDC), and spent 23 years in the field of healthcare epidemiology and infection control. Jarvis has served as consultant for many hospitals to help them decrease their central venous catheter bloodstream infection (CVC-BSI) rates.
He did cite one potential BIOPATCH risk though: local irritation. “This (and the fact that the initial study was done in adults) has led the FDA to recommend that the BIOPATCH not be used in low-birth-weight neonates in the first 10 to14 days of life,” Jarvis says. “On the other hand, Garland et al., have done a study in this population and showed that CVC-BSI and local-site infection rates are decreased with this product. Nevertheless, one does need to be cautious in using the BIOPATCH in the first two weeks of life in low-birth-weight neonates, and especially to insure that the antiseptic used for skin prep is dry before applying the BIOPATCH. No bacterial resistance to chlohexidine (the main ingredient in the BIOPATCH) has been found with the use of this product.”
Clinical Testing Ground
An enormous number of studies has been done to assess efficacy of the BIOPATCH in reducing the risk of CVC-BSIs, according to Jarvis.
“In fact, there have been [more than] 13 randomized controlled trials assessing this product. That is more than has been done to assess virtually any of the recommended products/interventions in any of the CDC or SHEA guidelines,” Jarvis says. “Furthermore, the FDA has given Johnson & Johnson and BIOPATCH the indication that this product reduces the risk of CVC-BSIs, local catheter site infections and skin bioburden at the IV site — the FDA does not permit an indication without first seeing and agreeing with the data, not just because a manufacturer wants such an indication.”
Jarvis says that in every study that has evaluated the BIOPATCH, the rate of CVC-BSIs and local site infections has decreased.
Two of the most recent studies involving BIOPATCH conclude that the product is effective in reducing infection. One, Ruschulte et al., was conducted by researchers from Hannover Medical School, in Hannover, Germany, and was published in the Annals of Hematology, in March 2009. The lead researcher is Heiner Ruschulte of the Hannover Medical School Department of Anesthesiology.
According to the study’s abstract, the objective was to evaluate efficacy of chlorhexidine-impregnated sponges for reducing catheter-related infections of central venous catheters inserted for cancer chemotherapy. The method? A randomized, prospective, open, controlled clinical study. The patients were from two high-dependency units at a university hospital and were undergoing chemotherapy for hematological or oncological malignancies, and required central venous catheters (CVCs) that were expected to remain in place for at least five days, according to the study.
The research included 601 patients with 9,731 catheterization days. They were studied between January 2004 and January 2006. The abstract continues, “Patients admitted for chemotherapy received chlorhexidine and silver sulfadiazine-impregnated triple-lumen CVCs under standardized conditions and were randomized to the groups receiving a chlorhexidine gluconate-impregnated wound dressing or a standard sterile dressing. Daily routine included clinical assessment of the insertion site (swelling, pain, redness), temperature, white blood count and C-reactive protein. Catheters remained in place until they were no longer needed or when a CVC-related infection was suspected. Infection was confirmed with blood cultures via the catheter lumina and peripheral blood cultures according to the time-to-positivity method. The incidence of CVC-related infections were 11.3 percent (34 of 301) and 6.3 percent (19 of 300) in the control and chlorhexidine-impregnated wound dressing groups, respectively. Especially, catheter-related infections at internal jugular vein insertions could be reduced.”
No negative consequences were observed, according to the study. The conclusion of the authors is that, “The use of chlorhexidine-impregnated wound dressings significantly reduced the incidence of CVC-related infections in patients receiving chemotherapy.”
Sure, the BIOPATCH fared well in the Ruschulte findings, but was the study well designed? Yes, according to Craig H. Gilliam, BSMT, CIC, director of quality development and infection control at Arkansas Children’s Hospital.
“They selected patients with types of cancer where you expect to have a central line used for a longer duration of catheterization—not just short term as one expects in surgical ICU patients. The insertion of CVC was performed by experienced practitioners in a controlled situation—this eliminated urgent placement by healthcare workers that have not demonstrated expertise in catheter insertion,” Gilliam says.
“The study was also limited to two years, so variation in practice that may occur over time will be limited and included a significant number of lines (601),” Gilliam continues. “I also thought the use of antiseptic central line and inspection by trained staff indicated a well-run unit that was using all technology to decrease the risk of catheter bloodstream infection. ...In a well-designed study using evidence based strategies to reduce catheter bloodstream infection, BIOPATCH was the significant difference in decreasing infection within a high-risk population.”
Gilliam has ample experience with BIOPATCH; Arkansas Children’s Hospital started using it in 2005.
“We had introduced other evidence-based strategies such as maximum-barrier precautions, antimicrobial impregnated catheters and daily checklist on need for CVC as reported in the British Medical Journal in 2007, (Bhutta is the lead author),” Gilliam says. “This was a concerted effort to use chlorhexidine products because of their superior performance in skin disinfection.”
His team started using the BIOPATCH® in the pediatric intensive care unit (PICU), and over the next two years noted a 55-percent reduction in catheter-bloodstream infections in the PICU.
“In 2006 we introduced BIOPATCH® in our NICU as part of a bundle to decrease infection and have eliminated Broviac catheter infections since December 2007, as reported in Neonatal Network’s May/June 2009 issue,” Gilliam says.
The results of the studies that have been done can “absolutely” be extrapolated to regard a wider swath of patients, according to Jarvis. There have been studies in ICU patients, neonatal ICU patients, pediatric patients, surgical patients and adult patients, he says. Two recent studies deserve special emphasis, according to Jarvis.
“In the [Ruschulte study], the authors asked the question, can use of the BIOPATCH reduce infections in high-risk oncology patients who already were using the insertion bundle and antiseptic impregnated catheters? They did a randomized controlled trial and found that the addition of the BIOPATCH led to an additional 46 percent decrease in CVC-related infections,” Jarvis says.
In a second study, Timset et al., (which ran in the March 2009 issue of the Journal of the American Medical Association) a randomized controlled study in seven ICUs (medical, surgical and med-surg) at three university and two general hospitals started with a “very very” low rate of CVC-BSI of 1.3 per 1,000 CVC-days, which is much lower than most U.S. hospitals have, according to Jarvis.
“Yet despite this low rate ... they were able to achieve a 76-percent reduction in CVC-related infections! These two studies, both published after the SHEA compendium was published, were not funded by Johnson & Johnson and are the strongest type of epidemiologic study one can design and conduct,” Jarvis says.
“With [more than] 13 randomized controlled studies (and many other non-randomized controlled studies), this technology has an enormous amount of clinical data documenting its efficacy,” Jarvis continues. “The various studies that have been done all show a decrease in catheter-related infections in a variety of patient populations and illustrate that virtually all patients would benefit from the use of this technology.”
The Timsit study Jarvis mentioned is titled, “Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults.” This randomized controlled trial was lead by researcher Jean-François Timsit, MD, PhD, and set out to prove whether use of a chlorhexidine gluconate–impregnated sponge (CHGIS) in intravascular catheter dressings can reduce catheter-related infections (CRIs).
The objective, specifically, was to “assess superiority of CHGIS dressings regarding the rate of major CRIs (clinical sepsis with or without bloodstream infection) and non-inferiority (less than 3 percent colonization-rate increase) of seven-day versus three-day dressing changes,” according to the abstract.
The trial occurred from December 2006 through June 2008 and included patients from seven intensive care units in three university hospitals and two general hospitals in France. Patients were older than 18 years, and were expected to require an arterial catheter, central-vein catheter or both for 48 hours or longer.
The use of CHGIS was compared and contrasted to standard dressings, which served as the control. There were scheduled changes of unsoiled adherent dressings every three days versus every seven days, with immediate change of soiled or leaky dressings.
The conclusion the authors reached is that “of CHGIS dressings with intravascular catheters in the intensive care unit reduced risk of infection even when background infection rates were low. Reducing the frequency of changing unsoiled adherent dressings from every three days to every seven days modestly reduces the total number of dressing changes and appears safe.”
The Bottom Line
Solutions are great, but if they are too expensive, they may not be realistic. The good news though, according to Jarvis, is that BIOPATCH is cost-effective overall.
“If you consider that a CVC-BSI costs between a minimum of $25,000 to $60,000 [and these are conservative figures, Jarvis says, the cost of use of the BIOPATCH, which can remain in place for seven days, thus reducing nursing time for dressing changes, is infinitesimal compared to the cost of a CVC-BSI—particularly when CMS and insurance companies are not going to be paying for vascular catheter related infections not present on admission,” he says.
Gilliam concurs: “In the Ruschulte study, a number-needed-to-treat ratio showed this was highly cost-effective.”
At Arkansas Children’s Hospital, Gilliam’s team measured about $110,000 in additional preventive costs (hand hygiene agents, maximum barrier precaution supplies, antibiotic impregnated catheters, chlorhexidine patches, antiseptics and wipes) over a five-year period, and found that the additional expense of BIOPATCH did not equal the attributable cost of a pediatric-ICU catheter-bloodstream infection.”