Healthcare Industry News: nosocomial infection
News Release - September 26, 2006
I-Flow Corporation Announces that a Human Study is Underway in Colorectal Surgery to Evaluate Antimicrobial Benefits of ON-Q(R)
Post-Surgical Pain Relief Device Being Studied as Broader Surgical Site Care TherapyLAKE FOREST, Calif.--(HSMN NewsFeed)--I-Flow Corporation (NASDAQ:IFLO ) announced today the beginning of a human study in colorectal surgery to evaluate the antimicrobial benefits of the ON-Q® PainBuster System, its market-leading post-surgical pain relief brand. The study, which will include utilization of the ON-Q SilverSoaker® Antimicrobial Catheter, will assess the rate of surgical site infections in colorectal patients who get ON-Q therapy versus those who do not and will be conducted at a number of locations across the United States. Two of the initial sites will be in Atlanta and Omaha. The multi-center trial is expected to include more than 1,000 patients and take more than a year to complete.
Currently, ON-Q is cleared by the FDA to significantly reduce pain better than narcotics and to significantly reduce narcotics intake after surgery. The pump delivers a non-narcotic local anesthetic (numbing medicine) automatically to an incision site. ON-Q was used successfully in hundreds of thousands of surgeries in 2005 in the United States to relieve post-surgical pain.
I-Flow is proceeding with this human study based on findings from a recently-completed animal study and on a meta-analysis of past ON-Q clinical study results that highlights reduced rates of surgical infections versus expected incidences. A total of 48 studies encompassing 3,011 patients were included in the analysis. The data, which was recently presented at the International Conference on Surgical Infections in Stockholm, Sweden, showed a significant benefit for continuous wound catheters, such as ON-Q, in lowering the risk of surgical site infection. Both quantitative and qualitative systematic review identified the benefit, and the data was confirmed in a sub-analysis by therapeutic area or specialty.
"Past data has shown that local anesthetics exhibit an antimicrobial benefit in-vitro and in-vivo," said Stephen M. Cohen, MD, a study investigator of Atlanta Colon and Rectal Surgery in Georgia. "Since ON-Q is used at the surgical site to deliver local anesthetic, we are expecting this study to show that ON-Q can reduce the incidence of surgical site infections."
"It isn't often that we're able to participate in a study that has this sort of potential, to truly expand the therapeutic scope of an already successful product," added Alan G. Thorson, MD, Clinical Associate Professor of Surgery and Program Director of Colon and Rectal Surgery at Creighton University in Omaha, Nebraska. "We have benefited from the positive outcomes that ON-Q delivers for our patients in relieving their pain after surgery, so now we're enthusiastic about exploring the potential antimicrobial benefits of the therapy."
According to the Center for Disease Control's (CDC's) National nosocomial infections Surveillance (NNIS) system, over 8% of colorectal surgery patients and an average of 2% of all surgery patients may develop surgical site infections, often increasing the length of stay in the hospital by an average of seven or more days and costing the healthcare system hundreds of millions of dollars each year.
"This is an exciting time for ON-Q, as we begin to research the therapy's potential benefits in reducing the incidence of surgical site infections," said Don M. Earhart, P-resident and CEO of I-Flow Corporation. "ON-Q is already redefining recovery for post-surgical patients across the country by providing superior pain relief so they get back to normal faster. This study is the next step in identifying a significant new market opportunity for an already successful technology."
About ON-Q
ON-Q is now labeled to significantly reduce pain better than narcotics and to significantly reduce narcotics intake after surgery. ON-Q is a simple yet elegant device that consists of a small balloon pump that holds a local anesthetic (a pain-numbing medicine) and delivers it automatically through a tiny, specially designed tube (catheter) to provide even distribution of local anesthetic over a wider area, as compared to other catheters, because of its patented wicking capabilities.
Currently, more than 50 studies on the use of ON-Q have been presented and published and more are underway to demonstrate the benefits of ON-Q in additional areas such as reduced infection risk, combination therapies (e.g., a local anesthetic and antibiotic mix, a combination of a local anesthetic and an anti-inflammatory), pediatrics, chronic pain and wound healing. To learn more about the benefits of ON-Q, visit www.AskYourSurgeon.com.
About I-Flow
I-Flow Corporation (www.iflo.com) designs, develops and markets technically advanced drug delivery systems that are redefining the standard of care by providing life enhancing, cost-effective solutions for pain relief.
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Source: I-Flow
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