New Products and Industry News

Resource for diabetes launched

  Shire plc (San Diego, CA) launched a new educational resource for people with diabetes and their caregivers as part HealTogether (www.HealTogether.com), its online community designed to increase awareness and education of diabetic foot ulcers (DFUs) and help patients better understand that DFUs should be treated immediately.

  The website provides a convenient resource for anyone affected by DFUs and includes educational content related to diabetes and diabetes-related complications, an animation that simplifies the complexity of DFUs, downloadable support material to help patients speak about their DFU with their healthcare provider, and a tool to help locate specialists for treatment. The website also includes a questionnaire to help determine who is at risk for a DFU and videos of patients being treated for their DFUs.

   www.HealTogether.com is the foundation of Shire’s nationwide HealTogether program, which is dedicated to promoting proper foot care for people with diabetes, educating individuals about DFUs, and encouraging those with nonhealing DFUs to talk to their physicians about seeing a wound care specialist.

   For more information, visit www.shire.com.

Wound care/surgical implant advisory board established

  Kerecis Limited (Reykjavik/Isafjordur, Iceland) announced the formation of a corporate scientific advisory board of recognized experts in wound care and surgical implants. The board will review the company’s progress in research and clinical development and help company management evaluate new scientific perspectives.

  The board will be chaired by Dr. Robert S. Kirsner, University of Miami; members include Dr. David Margolis (University of Pennsylvania), Dr. Magnus S. Agren (University of Copenhagen), and Madeleine Flanagan (University of Hertfordshire, UK).

  For more information, visit www.kerecis.com.

Changes proposed to 2014 Medicare OPP rule

  The Center for Medicare and Medicaid Services (CMS) proposed to update the OPPS market basket by 1.8% for calendar year 2014. The CMS also proposes to package seven new categories of supporting items and services. For many services, the CMS will continue to make separate payments if they are reported alone on a claim. Drugs will continue to be paid at ASP +6% non-pass-through drugs and biological separately payable under the OPPS.

  The CMS is proposing five new measures for the Outpatient Quality Reporting Program and the removal of two measures.

  For more information, visit www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1601-P.html.

International alliance created for pressure ulcer management

  An international collaboration was formed among the National Pressure Ulcer Advisory Panel (NPUAP), the European Pressure Ulcer Advisory Panel (EPUAP), and the Pan Pacific Pressure Injury Alliance (PPPIA). The PPPIA is an alliance formed between the Australian Wound Management Association, New Zealand Wound Care Society, Hong Kong Enterostomal Therapy Association, and Wound Healing Society of Singapore. The intent of the collaboration is to update the NPUAP and EPUAP Clinical Practice Guideline for the Prevention and Treatment of Pressure Ulcers (2009) based on new evidence.

  A 12-member Guideline Development Group conducted rigorous literature reviews, ranked the evidence for specific topics, and made recommendations for alterations or additions to the guideline. In the absence of definitive evidence, expert opinion and other international guidelines will be used to make recommendations. The resultant evidence-based guideline will be internationally relevant for healthcare professionals and consumers across all healthcare settings.

  Individuals and organizations with an interest in pressure ulcer prevention and treatment are invited to register their intent to be stakeholders in the review process.   For more information, visit www.internationalguideline.com/literature.

Cellular repair matrix efficacious for diabetic foot ulcers

  Osiris Therapeutics, Inc (Columbia, MD) reported its multicenter, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix® (a cellular repair matrix) to standard of care in patients with chronic diabetic foot ulcers met the prespecified stopping rules for overwhelming efficacy during a planned interim analysis.

  A total of 131 patients were enrolled; the interim analysis was conducted on the first 97 to complete the trial. For the primary endpoint, 62% of patients receiving the product had complete wound closure, compared to 21% (P <0.0001) of patients who received conventional treatment, a relative improvement of 191% and the largest ever reported from such a study. The trial also reached statistical significance in favor of the product on all top-line secondary endpoints, demonstrating faster wound closure and fewer treatments needed to achieve wound closure. In the cross-over phase of the trial, wounds that failed to close after 12 weeks of standard care had an 80% closure rate when switched to the study product. Patients receiving standard care were 74% more likely to experience an adverse event than persons using the study product (P = 0.008). As a result, the blinded phase of the trial is being discontinued immediately, and all patients randomized to the control arm will be offered treatment with the study product.

  For more information, visit www.osiris.com. This article was not subject to the Ostomy Wound Management peer-review process.