Wound Care Dressing Minimizes Use of Antibiotics in Some Heart Transplant Patients
The non-cytotoxic wound care dressing, called Arglaes, normally requires one application for up to seven days and has no known resistance.
Arglaes may have a substantial impact on the reduction of serious concerns relating to the potential development of overwhelming systemic or localized infections. Since it is not an invasive therapy with potential major side effects, and has not induced resistance to any known bacteria, it can have distinct advantages over antibiotics in certain situations.
Key is Silver in Controlled Release Polymer
Arglaes utilizes ionic silver in a patented controlled release polymer film to provide a barrier that helps protect against a broad spectrum of bacteria. It currently comes in the form of a transparent film and a transparent film with an absorbent calcium alginate pad.
Arglaes was used on a heart patient this past fall while being treated at Cleveland Clinic Heart Center. The 65-year-old patient developed a serious infection -- a resistant strain of pseudomonas aeruginosa -- a few weeks after being implanted with a left ventricular assist device (LVAD), which assists the heart with its function to take the oxygen-depleted blood from the body and deliver it to the lungs while the patient awaits a heart transplant. As the technology for LVADs improves, they also give patients mobility and allow for many normal activities prior to heart transplant surgery.
LVADs leave the body with a high risk for chronic infection at the site where the pump driveline exits the patient's abdomen, which is what occurred with this patient. The LVAD is powered by an external source, which means the patient has a hose -- or driveline -- protruding from the patient's abdomen, which is tethered to the power source. As a result, the line is subject to bacteria in the atmosphere and nosocomial (hospital-based) bacterial infections. Review of the data from various assist device programs approximate that 25-30% of all LVAD patients develop some kind of infection at the device's exit site from the body.
Complications and Expense with Antibiotics
Once an LVAD patient develops an infection, normal hospital protocol generally calls for immediate antibiotic therapy. In most cases, this means utilizing an aggressive, expensive regimen of intravenous antibiotics.
In addition to the high expense, antibiotic therapy can also lead to further complications, including increasing discomfort for the patient, increased risk of kidney failure, and greater chance of additional infection. If the infection does not respond to the antibiotics, the infection could become systemic and lead to sepsis related multi-organ failure and possibly even death.
In this patient's case, once the infection was identified, the Arglaes dressing was applied immediately around his LVAD driveline. The dressing was changed every three days. After day five, the infection showed significant improvement. The exudate from the site was virtually eliminated, the inflammation significantly reduced, and the localized pain had diminished.
Another benefit of Arglaes is the fact that it is transparent. The doctors and nurses could observe the infection without having to constantly remove the dressing which is less irritating to the wound and promotes quicker healing.
The Cleveland Clinic has since established a protocol in which Arglaes is used to help avoid antibiotic treatment and reduce the risk of infectious complications. The facility also is currently undertaking a formal clinical evaluation/trial of Arglaes on incision sites following heart surgery, including the chest, and legs and arms where arteries may be harvested for bypass operations.
"In light of the rise of antibiotic-resistant bacteria, the development of Arglaes is a major advancement in the battle against infection," said James T. Evans, M.D., FACS, Chief, Surgical Services at Overton Brooks VA Medical Center in Shreveport, LA.
Dr. Evans and his colleagues recently completed a comprehensive clinical trial using Arglaes on central venous catheter sites. The results showed that no organisms grew under an Arglaes dressing. But for patients who used non- medicated dressings, various organisms were found, including MRSA, staph aureus, staph epi, e coli and candida.
NYU Surgeon Helps Prevents Infection with ArglaesM
Arglaes is creating such a keen interest across the medical field that prominent physicians and health professionals are quickly implementing clinical and scientific studies using the new product.
"Arglaes, a silver impregnated dressing, appears to have a significant advantage in reducing the incidence of infection," said Dr. Colvin, Chief of Cardiothoracic Surgery and Director of the Cardiothoracic Surgery Residency Program, NYU School of Medicine. "This leads to better outcomes for the patient; they're in the hospital for less time, they need fewer antibiotics, and they are able to recover more quickly and completely."
Dr. Colvin, a pioneer in the development of minimally invasive cardiac surgery, as well as the NYU cardiothoracic surgery group, are using Arglaes at the incision sites of all their patients to help reduce the risk of infection.
The Power of Ionic Silver and Controlled-Released Polymers
Silver has long been known as a potent antimicrobial agent. Silver sulfadiazine, for instance, is commonly used as a treatment for burn patients and for other wound care applications. However, silver as it is currently used has some inherent problems, chiefly it is rapidly neutralized when it comes in contact with body fluids and, therefore, requires frequent doses to maintain efficacy; and, in large quantities, silver is toxic.
However, the silver used in Arglaes is in its ionic state, which is more effective as an antimicrobial than the silver metal itself. And the dose required to achieve microbial control is substantially less than normal silver bearing compounds, and therefore, is non-cytotoxic.
The ionic silver is released at a constant rate through controlled-release polymers, which are added to the dressing during the manufacturing process. The silver forms an antimicrobial barrier that helps prevent microorganisms from accessing the wound site. Arglaes maintains full efficacy for seven days, releasing a constant stream of silver, calcium and sodium ions. The silver ions are released at the same rate in the presence of a microscopic quantity of moisture vapor or a large quantity of fluid.
Arglaes was developed by Maersk Medical, Inc., based in England. Medline Industries Inc. (Mundelein, IL) has the exclusive distribution and marketing rights in the United States.