New Products and Industry News June

Abdomen dressing receives FDA clearance

     Kinetic Concepts Inc (KCI, San Antonio, TX) recently received 510(k) clearance from the US Food and Drug Administration (FDA) to market its ABThera™ Open Abdomen Dressing. Earlier this year, the FDA cleared the ABThera™ Open Abdomen Negative Pressure Therapy Unit. Together, the ABThera™ Open Abdomen Negative Pressure Therapy System will be indicated for temporary bridging of abdominal wall openings where primary closure is not possible or where repeat abdominal entries are necessary.

     The proprietary system is intended for open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The system is designed to improve therapy in the management of the complex open abdomen by reducing interstitial edema, actively removing fluids and infectious material, thus assisting in primary fascial closure of the abdominal wall. The system expands the offerings of KCI’s negative pressure technology platform into the surgical and trauma operating theaters.

     For more information, visit www.kci1.com.

Product line serves as defense against pressure ulcers

     Foamex (Media, PA), a producer of polyurethane foam-based solutions and specialty comfort products, introduces BodyZone™ and BodyZone™ Ultra, two new solutions for pressure ulcer prevention and treatment. The company developed these new products to reduce the clinical occurrence of pressure ulcers that can result from long-term care. In independent testing, the solution’s support surfaces demonstrated superior performance over other brands by neutralizing pressure, heat, moisture, friction, and shear, the factors that lead to dermal and tissue breakdown.

     In order to prevent pressure from forming, the company’s engineers worked with specialty designs and the company’s latest generation of highly breathable memory foams to enhance the performance of its support surfaces portfolio. Independent testing of these advancements illustrated that the solution’s technology delivers the lowest average and maximum pressure readings and the highest body envelopment scores for better comfort and care.

     For more information, visit www.foamex.com.

Hydrogel successfully reduces patient pain during dressing changes

     MPM Medical Inc’s (Irving, TX) Regenecare® HA Hydrogel has been found to reduce pain when used before and during wound dressing changes. Patients consistently rate the changing of wound dressings as the time of greatest pain. In a recent study, a total of 60 patients received the first dressing change without the use of the gel or any form of pain medication. The gel then was used during subsequent dressing changes. Based on a 10-level scale, patient-reported pain averaged 6.8 before gel use. When the gel was used before and after dressing changes, patient-reported pain averaged 2.3 — a nearly 70% reduction. The pain-reducing benefits were attributed to the gel’s 2% lidocaine-HCI, its high molecular weight of aloe vera extract, and marine collagen, a natural humectant and moisturizer. This combination of ingredients has been shown to enhance wound repair mechanisms within the epidermis.

     For more information, visit www.mpmmed.com.

Antimicrobial dressing claims receive FDA clearance

     Mölnlycke Health Care (Norcross, GA) recently received FDA clearance to support two new claims for Melgisorb® Ag, a highly absorbent, antimicrobial dressing. The dressing absorbs up to 45% more than the market-leading silver hydrofiber dressing and the high fiber strength allows for removal in one piece. The dressing may be used under compression bandages and offers sustained release of silver for up to 14 days and is now indicated for use on partial-thickness burns. This is in addition to the management of moderate to heavily exuding partial-thickness wounds such as surgical wounds, trauma injuries, leg ulcers, pressure ulcers, diabetic/neuropathic ulcers, and graft/donor sites.

     For more information, visit www.molnlycke.com.

Clinician reports rapid healing of intractable wounds after using Manuka honey

     At the 22nd annual Symposium on Advanced Wound Care (SAWC), Derma Sciences (Princeton, NJ) revealed details of a recently concluded 11-patient venous leg ulcer (VLU) case series involving the use of the company’s Medihoney®. The study was a confirmatory case series following a 108-pateint randomized controlled study that was published in 2008 on a similar patient population, all of whom had nonhealing VLUs.

     The recent case series included 11 patients with VLUs that had not healed with other advanced wound care modalities including the gold standard multilayered compression as well as silver antimicrobial dressings, hyperbaric oxygen therapy, and antibiotic therapy used for at least 4 months. The study was designed to measure the percentage of wounds that healed in the standard timeframe of 12 weeks, but all 11 wounds healed within 6 weeks, with more than half healing within 4 weeks.

     For more information, visit www.dermasciences.com.

Collagen-based topical gel receives formulation enhancements

     Cardium Therapeutics (San Diego, CA) and its subsidiary Tissue Repair Company (TRC) announced significant new formulation enhancements for Excellarate™, designed to simplify and broaden the use of the product for diabetic ulcers. The enhancements will expand the potential applicability into a number of additional wound healing market opportunities, including pressure and venous stasis ulcers, as well as major surgical and serious trauma wounds.

     The product is a collagen-based topical gel employing TRC’s Gene Activated Matrix™ (GAM) technology to stimulate a patient’s cells to produce a sustained microrelease of platelet-derived growth factor-B (PDGF-B) protein directly within the patient’s wound. PDGF-B is believed to stimulate angiogenesis and granulation tissue formation through the recruitment and proliferation of cells such as monocytes, fibroblasts, and endothelial cells, all of which are critical for the effective stimulation of a variety of wound healing processes.

     On May 6, 2009, Cardium announced the completion of recruitment for the Phase 2b MATRIX clinical trial to evaluate the safety and efficacy of the product for the treatment of nonhealing diabetic foot ulcers. The MATRIX Data and Safety Monitoring Board has reviewed safety data collected from study participants as of April 21, 2009 and reported the product appears to be both safe and well tolerated, with no serious adverse events. Approximately 70% of the patients recruited into the study already have completed their initial evaluation period with respect to key efficacy criteria, particularly the percentage of patients achieving complete wound closure, the rate of wound closure, and the reduction of wound size at various time points.

     For more information, visit www.cardiumthx.com.

Web-based service to help reduce dressing-related pain

     Mölnlycke Health Care (Gothenburg, Sweden) announced the launch of their new web-based Less-Pain™ Academy during the 19th Annual Conference of the European Wound Management Association (EWMA), Helsinki, Finland, May 20–22, 2009. The website program is designed for healthcare practitioners actively involved in wound dressing changes. The new website (www.less-pain.com) provides access to the latest research, therapies, protocols, and best practices. The goal of the initiative is to help professionals improve patient quality of life by raising the awareness of dressing-related pain and presenting tools to achieve changes in practice. The initiative has been endorsed by the EWMA.

     The key element of the program will be a series of live seminars and web-based lectures led by renowned specialists. The focus will be on essential aspects of pain awareness, management, and assessment; impact on quality of life; wound healing; and practical tools to improve outcomes. The online lectures will be available as podcasts for downloading and study.

     For more information, contact info.less-pain@molnlycke.com.

Oxidizing solution gains approval from the US EPA

     Integrated Environmental Technologies Ltd (Little River, SC) and Benchmark Research & Technology (Houston, TX) announced that the US Environmental Protection Agency (EPA) has approved EcaFlo® Anolyte (trademarked Excelyte®) as a registered and effective biocide against methicillin-resistant Staphylococcus aureus (MRSA).

     The product is a nontoxic, oxidizing solution that destroys MRSA, Escherichia coli, salmonella, hepatitis C, tubercle bacillus, and almost every other pathogen in a manner that prevents them from mutating; thereby, preventing the development of new resistant micro-organisms. The EPA approved the solution as a high-level disinfectant/biocide. Since gaining EPA registration, the biocide has quickly gained momentum and is fast becoming the microbiocide of choice for hospitals, universities, public school systems, medical and veterinary schools, and medical research labs. University General Hospital (Houston, Tex) announced that it would be the first hospital in the country to implement the solution as its disinfecting agent.

     For more information, visit www.ietecaflo.com.