Medical Device Daily

Hospital infections are not only difficult to treat, they're becoming more difficult to treat.

That unhappy fact offers an opportunity for the Biopatch.

The use of an antimicrobial dressing that includes chlorhexidine gluconate has been shown to have an antimicrobial effect against a variety of infectious agents often associated with the use of catheters and other percutaneous devices, according to a new study.

Study results of the chlorhexidine gluconate antispectic which is impregnated in the Biopatch — recently published in Infection Control and Hospital Epidemiology — showed that treatment with this dressing could be an effective therapy against a range of infectious agents including antibiotic-resistant strains of staphylococci and enterococci.

The Biopatch is made by Johnson & Johnson Wound Management, a division of Ethicon (both Somerville, New Jersey), a company of J&J (New Brunswick, New Jersey).

Chlorhexidine gluconate is a broad-spectrum antimicrobial and anti-fungal agent that is released for up to seven days via the Biopatch dressing. When applied to any percutaneous catheter site, the dressing helps reduce catheter tip colonization and bloodstream infection, according to J&J Wound Management. “In addition, the dressing can absorb up to eight times its own weight in fluid and provides a one-inch zone of inhibition from the insertion site.“

“The big news [from the study] for us is that we continue to see resistant strains of microbes in the hospitals, and this proves that the Biopatch is effective against these and many others,“ Amy Firsching, public relations manager for Ethicon and J&J Wound Management, told Medical Device Daily.

In the study researchers evaluated the effectiveness of Biopatch dressing, a sterile polyurethane foam with 250 micrograms of chlorhexidine gluconate per milligram of disc, in activity against the primary organisms associated with infections related to the use of catheters or other percutaneous devices.

The researchers compared the effectiveness of Biopatch dressing to the use of sterile polyurethane foam without chlorhexidine gluconate against antibiotic-resistant clinical isolates and 10 of the most common organisms found in percutaneous device-related infections.

The use of chlorhexidine gluconate foam led to consistent zones of inhibition against all challenge organisms, indicating that infectious agents were killed or inhibited by the chlorhexidine gluconate. No zones of inhibition were observed in foam that did not include chlorhexidine gluconate.

Sales of the Biopatch are targeted to hospitals, wound care facilities, orthopedic facilities and any other facilities doing surgeries, Firsching said.

Whenever intact skin is interrupted, treatment involving subcutaneous devices is known to create a tract along which microorganisms can enter the body and cause infection. The most common cause of catheter-related infection is Staphylococcus epidermidis (S. epidermidis).

Its applications are for vascular and non-vascular percutaneous devices, IV catheters and central venous lines, or “even dialysis catheters, drains or test tubes,“ according to Firsching.

Shubhangi Bhende, corporate Microbiology and Sterilization Services, Ethicon, said, “The results of this in vitro study indicated that the polyurethane foam with chlorhexidine gluconate is efficacious against infectious agents associated with the use of percutaneous catheters. Importantly, this treatment was shown to be effective against antibiotic-resistant infectious agents that represent some of the most serious health risks for patients treated with catheters.“

Researchers at the Department of Health Policy at Jefferson Medical School recently estimated that, in the U.S., up to 3,900 patient lives close to $2 billion could be saved each year because of catheter-related infections if an antimicrobial dressing containing chlorhexidine gluconate was universally adopted.

“This study provides us with further support for the prophylactic use of antimicrobial dressing that includes chlorhexidine gluconate in helping to reduce the risk of catheter-related infection for thousands of patients each year who are treated with catheters and other percutaneous therapies,“ said Bhende said.

The microbial challenges consisted of clinical isolates including methicillin-resistant S. epidermidis and S. aureus; E.faecalis; vancomycin-resistant E. faecium; C. albicans; and Pseudomonas aeruginosa. Consistent zones of inhibition were observed under and around the chlorhexidine treatment foam for all of the challenge organisms. The safety and effectiveness of Biopatch Antimicrobial Dressing has not been established in children under 16 years of age.

The study was funded by J&J Wound Management.