World’s largest clinical trial on copper a success at Sentara
Sentara Leigh Hospital trial published in peer-reviewed journal, presented at national conference
A 10-month clinical trial at Sentara Leigh Hospital in Norfolk, Va. has determined that hard surfaces and linens infused with copper oxide compounds contributed to an 83 percent reduction in C-difficile and a 78 percent overall reduction in multi-drug resistant organisms (MDROs) including C-diff, MRSA and VRE in a real-world clinical environment. These results occurred in a hospital with a robust protocol for managing infection risk certified by the health care accrediting body DNV-GL Healthcare.
The results of the trial were published in the peer-reviewed American Journal of Infection Control on Sept. 28, 2016 and will be presented at the annual conference of the Infectious Disease Society of America in New Orleans on Oct. 27, 2016.
“We’ve just about reached the limit of human processes to control infections in hospitals and Sentara Leigh was already performing pretty well,” said Gene Burke, M.D., vice president and executive medical director for clinical effectiveness with Sentara Healthcare. “We owe it to our patients to try new approaches and this clinical trial indicates that copper-infused products are an effective addition to a robust infection prevention program.” Sentara is an integrated not-for-profit system with 12 hospitals in Virginia and North Carolina.
“Our experiment with copper products and the clinical trial just published reflects the Sentara commitment to innovation,” says Howard P. Kern, president and CEO of Sentara Healthcare. “We are relentless in the pursuit of improved clinical outcomes and an exceptional patient experience and these copper products are helping us achieve both of those goals.”
“These results suggest that antimicrobial surfaces and linens may have substantial impact in reducing HAIs due to problematic MDROs in a hospital that has already employed aggressive infection control measures and has low rates of HAIs,” according to the study paper, which was co-authored by Costi Sifri, M.D., an associate professor of medicine and director of hospital epidemiology at the University of Virginia Health System in Charlottesville, Va., and Kyle Enfield, M.D., associate professor medicine at the University of Virginia School of Medicine.
Patient data were analyzed from the highest-touch surfaces in patient rooms including rolling bedside tables and hand rails on the sides of patient beds, plus bed linens, gowns and washcloths that came into direct contact with patients.
Three companies engaged in clinical trial
Sentara Healthcare partnered with Richmond, Virginia-based Cupron, Inc., which invented the proprietary copper oxide technology used in the surfaces and textiles, and Norfolk, Virginia-based EOS Surfaces, LLC, which developed the unique copper oxide-impregnated hard surfaces. EOS Surfaces manufactured custom-made countertops, bathroom sinks, bedside tables and bedrails that were installed in 124 patient rooms in the newly-built East Tower at Sentara Leigh, plus copper-infused work surfaces at nursing and charting stations, in soil rooms and other common areas.
Cupron, Inc. produces Cupron Medical Textiles including bedsheets, pillow cases, thermal blankets and patient gowns, plus towels, wash cloths and bath blankets used in patients’ private bathrooms. A 1970s-era patient wing which did not receive copper products served as control during construction of the West Tower.
“We went into this study focused on the fidelity of the data,” said Gene Burke. “We wanted to find out if these copper products would contribute to additional improvement in our clinical outcomes and they did.”
EOScu, produced by EOS Surfaces, LLC, is trademarked as a Preventive I Biocidal™ and the only synthetic hard surface registered by the Environmental Protection Agency as a bacterial sanitizer proven to kill 99.9 percent of bacteria within two hours of contact. The EPA granted federal registration only after EOS submitted 14,000 production samples for rigorous testing and validation of efficacy claims.
“It was all or nothing,” says Ken Trinder, president of EOS Surfaces, LLC. “EPA registration gives us credibility and opens the door to real conversations with people looking to improve their clinical performance.
“Put aside the financial aspect of infections,” Trinder adds. “Finding out our products really do prevent these pathogens from getting to patients, that’s huge, and it’s rewarding for everybody who worked on this trial.”
The copper-infused linens produced by Cupron, Inc. help prevent bacteria in perspiration and body fluids from contributing to infections caused by direct contact with damp, contaminated cloth materials.
“Studies show that patient gowns and bed linens are the two most contaminated surfaces in a room,” says Chris Andrews, CEO of Cupron, Inc. “With our sheets and gowns, all the soft surfaces with which the patient has intimate contact are actively killing bacteria.” Andrews adds that the scope and setting of the trial lends credibility to the results.
“We’re moving past theory to actual clinical results in a very complicated environment,” Andrews says. “We think this is a great opportunity to examine a novel idea for battling pathogens in the healthcare setting.”
Copper products require no new processes, staff training or special maintenance, Dr. Burke adds, but still provide an active barrier to infection.
“We sanitize or terminal clean patient rooms every day, but that leaves 23-and-a-half hours for bacteria to proliferate,” said Burke. “Copper keeps killing bacteria around the clock and our clinical trial demonstrates that copper-infused products can be a practical, affordable solution to augment disinfection protocols.”
Test sites included new and old hospital towers
The first copper clinical trial was conducted in the midst of a challenging on-site replacement for Sentara Leigh Hospital, a 1970s-era facility in Norfolk, Va. As part of the new construction, copper-infused hard products were built into the first of two replacement bed towers and copper-infused linens were deployed. The remaining 1977 wing did not receive copper products. The trial took into account that the new tower housed mainly surgery patients, while the old tower housed mainly medicine patients with chronic conditions. Co-morbidities, demographics and other factors were taken into account in assessing the data.
The study also notes that during the time of the trial, Sentara Leigh Hospital voluntarily undertook a protocol through its accrediting body, DNV-GL, to achieve the agency’s certification in Managing Infection Risk. Sentara Leigh Hospital and Sentara Virginia Beach General Hospital were the first hospitals in the world to achieve this certification from DNV-GL.
Second study seeks additional clinical data
Sentara Leigh Hospital opened its second new patient tower, the West Tower, to patients in April 2015. To further assess the effectiveness of copper-infused products, a second paper is being drafted on a second clinical trial comparing the use of copper products in all 250 licensed beds in both new patient towers at Sentara Leigh Hospital against two other Sentara hospitals. One of those two other sites is Sentara Virginia Beach General Hospital, built in 1965 and incrementally modernized and expanded. The other is Sentara Princess Anne Hospital, also in Virginia Beach, which opened in 2011. Results of the second clinical trial are expected to be published in 2017.
Sentara is committed to copper
Sentara Healthcare is confident enough in the effectiveness of copper in controlling hospital-acquired infections that copper-infused hard products such as bedside tables and bed rails will be retro-fitted in all 12 Sentara hospitals and copper-infused linens will be deployed in all patient rooms. Sentara is also examining the potential for copper products in its nursing and assisted living centers.
“I firmly believe it won’t take that many avoided infections before we’re on the right side of the ledger here,” says Robert Broermann, chief financial officer of Sentara Healthcare. “It’s not every day you see these kinds of opportunities to improve patient safety and clinical quality at a relatively modest investment level that stand a good chance of generating a positive return on investment.” Broermann adds that the trend toward quality-based reimbursement from Medicare and other payers is an additional justification for investing in copper-infused products.
“Healthcare associated infections are becoming a national dilemma and having an additional tool to help combat those is absolutely vital to meeting the expectations of our patients,” says Dr. Gene Burke of Sentara. “This, to me, is the beginning of a new wave of technologies to help solve those problems.”