TWC News Update

KCI Acquires Systagenix for $485 million

  Kinetic Concepts Inc. (KCI), San Antonio, TX, has signed a definitive agreement to acquire United Kingdom-based Systagenix, a provider of advanced wound care (AWC) products, in a move that’s expected to augment KCI’s global position as a leading wound care company with a diverse product portfolio. According to KCI officials, the purchase will cost $485 million.    “The acquisition of Systagenix advances our strategy and vision as the global leader in transformational healing solutions,” said Joe Woody, president and CEO at KCI. “This major strategic investment will diversify KCI’s global portfolio of wound care products and reinforces our competitive advantage as the trusted ‘gold standard’ in wound healing. The combination of KCI and Systagenix creates a winning platform across the entire wound care continuum. It increases our ability to address the complete wound healing needs of clinicians and their patients with best-in-class outcomes that help to reduce the overall cost of patient care.”   The transaction also provides KCI with increased access to the $3.4 billion AWC market, which reportedly has an overall category growth of 3-5%. Systagenix has a meaningful presence in the AWC market and is the market leader in collagen dressings, officials said. Moreover, as part of KCI, Systagenix’ strength in the growing categories of foam and contact layers can be leveraged to capture increased market share. Many of Systagenix’ products are complementary and are often used before, during, and after use of KCI’s core negative pressure wound therapy (NPWT) products. The acquisition builds on KCI’s recent acquisition of the CelluTome™ System epigrafting technology.   Systagenix includes a broad portfolio of AWC products with a focus on moist wound healing dressings – including PROMOGRAN PRISMA,® reportedly the collagen dressing market leader, TIELLE,® (foam) and ADAPTIC® (non adherent contact layers). Systagenix’ distributes more than 20 million AWC dressings each month to more than 100 countries. The company, formerly part of Johnson & Johnson, has approximately 800 employees worldwide, including an experienced team of research and development scientists.   In connection with the transaction, One Equity Partners LLC (OEP) will spin off an early-stage diagnostics business out of Systagenix, which will be held and operated by OEP as a standalone business following the acquisition. In addition, KCI will enter into a long-term strategic relationship with the diagnostics business for the distribution of WOUNDCHEK™ Protease Status. WOUNDCHEK is the flagship product of the Systagenix diagnostics business, designed to help clinicians rapidly assess and target advanced wound care therapies more effectively.   The acquisition is subject to customary closing conditions, including applicable antitrust approvals, and is expected to close in the fourth quarter of 2013.

Wound Ostomy Nurses Produce Outcomes, Study Claims

  The Wound, Ostomy and Continence Nurses Society™ (WOCN®) has released the results of a recent research study that reportedly shows wound, ostomy, and continence (WOC) nurses play key factors in achieving better patient outcomes related to WOC conditions. The study, “Effectiveness of Wound, Ostomy and Continence Nurses on Agency-Level Wound and Incontinence Outcomes in Home Care,” is said to be the largest, most comprehensive study undertaken on WOC care. Results also found that facilities with WOC nurses had significantly better patient improvement and stabilization in services for wounds, incontinence, and urinary tract infections compared to facilities without WOC nurses, officials said.   In the more than 400,000 episodes of care included in the study, home healthcare (HHC) patients treated by a WOC nurse improved dramatically compared to HHC patients without a WOC nurse. The numbers find patients were also more than 2.3 times likely to have stabilization of urinary incontinence, 1.2 times as likely to have stabilization of urinary tract infections, and 1.16 times as likely to have stabilization of fecal incontinence.    “WOC nursing is a multifaceted, evidence-based practice incorporating a unique body of knowledge that adheres to high standards of practice cultivated by the American Nurses Association,” said Kate Lawrence, MSN, RN, CWOCN, president of WOCN. “This study proves that WOC care results in better patient outcomes, which translates into lower patient care costs.”   In addition to the aforementioned results, the study also found that patients were nearly twice as likely to have improvement in pressure ulcers, 20% more likely to have improvement in lower extremity ulcers, and 14% more likely to have improvement in bowel incontinence.    “WOC nurses are invaluable to employers,” Lawrence said. “Evidence from our study showed that patient outcomes improve and WOC care can prevent readmissions. WOC care also helps ensure home care agencies get the maximum payout from Medicare and Medicaid.”   The study was funded by a WOCN grant to a team of investigators at the University of Minnesota School of Nursing. Chartered in 2010, the study successfully met its goals to compare both incidence and patient outcomes in pressure ulcers, stasis ulcers, surgical wounds, urinary/bowel incontinence, and urinary tract infections for patients and facilities with and without WOC nurses, officials said.    “We’ve always assumed that WOC education and certification make a difference,” said Bonnie Westra, PhD, RN, FAAN, FACMI, associate professor at the University of Minnesota School of Nursing. “We now have evidence that proves they make a difference.”

Children’s Hospital Launches Pediatric Ulcer Program

  A new study has led one pediatric facility to change it’s protocols for how children are cared for after it was learned that too many kids were experiencing pressure wounds. Researchers at Cincinnati Children’s Hospital Medical Center have reportedly uncovered a high number of children living with pressure ulcers, and they claim the cause is associated with the use of medical devices such as facemasks used for delivering mechanical ventilation, tracheotomy tubes, pulse oximeters, and orthopedic casts. A recent study at the facility included the development of a quality improvement initiative that has reduced pressure ulcers at the medical center by 50%, according to officials. A host of solutions are said to have resulted in a 50% reduction in pressure ulcers in the pediatric ICU one year after implementation and are expected to be adopted by other hospitals.    “While often life-saving, these devices can cause pressure ulcers that can be quite serious,” said Marty Visscher, PhD, director of the skin sciences program at Cincinnati Children’s and lead author of the study, which was preceded by an unscientific survey taken at the hospital that reportedly revealed a rate of pressure ulcers in children of at least 10%, more than twice as high as was thought to occur in pediatrics. “Their incidence is higher in critically ill patients, with increased infection, pain, and prolonged hospitalization,” Visscher said.   Cincinnati Children’s also assembled a patient-safety collaborative to investigate the problem. While more than 70% of pressure ulcers in adults occur due to pressure over bony parts of the body, researchers discovered most of those in children occur due to medical devices.    “While this initial intervention has proved to be efficacious, we need to use established skin evaluation methods, identify early tissue changes, and test additional interventions to reduce harm from medical devices,” Visscher added. “The unanticipated increase in pressure ulcers from pulse oximeters indicates that new products must be evaluated before widespread use.”   A pediatric advanced wound and skin service that includes wound treatment throughout the medical center has also been launched at the hospital, as well as academic research on skin and wound healing, according to officials.

Wound Clinic Nurse Joins Haiti Mission

  Michele Slootmaker, BSN, RN, was recently among a group of healthcare professionals who cared for children during a medical mission trip to Haiti. It was her first mission trip, which she joined through her involvement with her Denville-based church. The healthcare team treated more than 300 patients over a three-day period, offering care in clinics, including those set up in orphanages, according to a report by NorthJersey.com.   A nurse at Chilton Hospital’s Comprehensive Wound Healing and Hyperbaric Center, Pequannock, NJ, Slootmaker was stationed near the city of Cap-Haitien in northern Haiti, a poverty-stricken community. She was also accompanied by her husband Andrew, a chiropractor.

Report Claims Ultrasound Could Cure Leg Ulcers

  Chronic venous ulcers have reportedly been successfully healed by direct application of low-frequency and low-intensity ultrasound, according to a small pilot study. The study, conducted by Drexel University, Philadelphia, included five patients whose lower extremity ulcers were treated with 20 kHz for 15 minutes and completely healed in four weeks. The effect size for that 20 kHz/15 minute treatment was large, at 0.96, when compared with sham ultrasound treatment, and no adverse effects were seen, the researchers, led by Peter A. Lewin, PhD, reported in the August issue of Journal of the Acoustical Society of America.   Previous studies had suggested the possibility of therapeutic utility for ultrasound in wound healing, but have used high frequencies ranging from 1-3 mHz, and definitive evidence has been lacking.   For the study, researchers enrolled 20 adult patients living with venous ulcers of at least 2 months’ duration and a CEAP (clinical severity, etiology, anatomy, pathophysiology) venous wound classification of 6. Patients all reportedly had standard wound care including debridement and compression, and were randomized to one of four ultrasound groups: 20 kHz for 15 minutes, 20 kHz for 45 minutes, 100 kHz for 15 minutes, or sham. Treatment was given once weekly.   The intensity level of 100 mW/cm² was chosen because the American Institute of Ultrasound in Medicine has deemed that to be safe even for lengthy exposure times. Other ultrasound parameters were a pulse repetition frequency of 1 Hz and a 50% duty cycle. The battery-powered ultrasound applicator, wrapped in sterile dressing, was placed on the wound and held in place with surgical tape. Whereas all five patients in the 20 kHz/15 minute group achieved complete healing, only two patients in the 100 kHz/15 minute and sham groups healed, as did only one in the 20 kHz/45 minute group. During the month-long treatment, healing was significantly faster in the 20 kHz/15 minute group than in the other groups (P2 versus 4.8 cm²), “showing that wounds of the same size, when treated with ultrasound did heal, whereas those not treated did not heal,” Lewin said. To further examine the effects of ultrasound at the cellular level, researchers also conducted in vitro experiments in which cultured mouse fibroblasts were exposed to 20 kHz for 15 minutes at intensities of 100, 50, or 200 mW/cm². Compared with control cells, the fibroblasts exposed to 20 kHz/15 minute at 100 mW/cm² showed a 35% increase in proliferation (PFDA Issues Warning Regarding Illegal Diabetes Treatments   The US Food and Drug Administration (FDA) has taken action to remove illegal diabetes care products, including some items labeled as “dietary supplements,” that claim to mitigate, treat, cure, or prevent diabetes and related complications from the market. The agency recently issued letters warning 15 companies that the sale of their illegally marketed products violates federal law. The letters were sent to foreign and domestic companies whose products were sold online and in retail stores.   FDA officials are also advising consumers not to use these or similar products because they may contain harmful ingredients or may be otherwise unsafe, or may improperly be marketed as over-the-counter products when they should be marketed as prescription products. Using these products could cause patients to delay seeking proper medical treatment for their diabetes.    “Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments,” said FDA commissioner Margaret A. Hamburg, MD. “Consumers who buy violative products that claim to be treatments are not only putting themselves at risk, but also may not be seeking necessary medical attention, which could affect their diabetes management.”   Many of the illegally sold products that are the subject to the FDA’s actions include claims such as “prevents and treats diabetes,” and “can replace medicine in the treatment of diabetes.” In addition, some of the products may cause harm because the products contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards.   The FDA has requested a written response from these companies stating how they will correct the violations. Failure to promptly correct the violations may result in legal action, including product seizure, injunction, and/or criminal prosecution.   As of the warnings, FDA officials said they weren’t aware of any reports of injury or illness associated with the illegally sold products. The FDA asks healthcare professionals and consumers to report any suspected associated adverse reactions to www.fda.gov/medwatch/report.htm.

Shire Launches Diabetes Educational Resource for Patients

  Officials with Shire Regenerative Medicine have announced the release of an online educational resource for people living with diabetes and their caregivers as part of the company’s HealTogether national awareness program.   Accessible at www.healtogether.com, the online community is designed to increase awareness and education of diabetic foot ulcers (DFUs) and to help patients better understand that DFUs should be treated immediately.   The site includes numerous pages of educational content related to diabetes and diabetes-related complications, including an animation that simplifies the complexity of DFUs, downloadable support material that helps patients speak about their DFUs with their healthcare providers, and a tool to assist in the location of specialists for treatment. The website also includes a questionnaire to help determine who is at risk for DFUs and videos of patients who are being treated for their DFUs.   “Because an untreated DFU can become chronic and lead to a serious complication, such as amputation, we want to provide as much education as possible to avoid this outcome and help patients understand that they’re not alone — there is help and support available,” said Lee C. Rogers, DPM, co-medical director of the Amputation Prevention Center at Valley Presbyterian Hospital in Van Nuys, CA.