August New Products and Industry News

New Products

Barrier cream samples offered through social media site
  3M Skin & Wound Care, a division of 3M (St. Paul, MN), is offering a sampling program for its new Fragrance Free version of 3M™ Cavilon™ Durable Barrier Cream through its Twitter site (https://www.twitter.com/#!/3M_Cavilon). The CHG-compatible moisturizing cream is targeted toward patients with severely dry or at-risk skin from damage associated with incontinence.

  Healthcare professionals can follow the company and send a direct message with their shipping information to request the samples. The product will be offered on the company’s website within the next couple months as well.

  For more information, visit www.3M.com/Cavilon.

Sacral nerve stimulation device reduces episodes of incontinence
  Medtronic Inc (Minneapolis, MN), a medical device company, released new data on its InterStim system that revealed reduced episodes of incontinence and increased quality of life at three years’ follow-up for a majority of patients.

  The implantable device uses mild electrical stimulation of the sacral nerves to influence the behavior of the pelvic floor muscles and bowel. The new study found that 86% of the 77 study participants reported a reduction of incontinent episodes by at least half, and the number of episodes per week decreased from a mean of 9.4 to 1.7. Forty percent of the participants reached complete continence.

  For more information, visit www.medtronic.com.

Positive results announced for Phase IIb trial of cell-based therapy in venous leg ulcers
  Healthpoint Biotherapeutics (Forth Worth, TX) announced positive results for its Phase IIb clinical trial examining the value of HP802-247, an investigational allogeneic living cell suspension containing keratinocytes and fibroblasts, in venous leg ulcers. The two components are sprayed sequentially on the wound bed and become trapped on the wound surface in a thin fibrin matrix that is anticipated to stimulate the patient’s own cells to heal the wound.

  The study was designed to determine the potential effectiveness of two cell concentrations and two dosing frequencies of HP807-247, when combined with standard care, compared to control plus standard care, in healing venous leg ulcers over a 12-week treatment period. Average percent change from baseline in the target wound area over the 12-week double-blind treatment (P = 0.04), and time in days to complete wound closure from baseline (P = 0.02) both achieved statistical significance.

  The company is looking to meet with the US Food and Drug Administration to review findings and propose plans for the next phase of research.

  For more information, visit www.Healthpointbio.com.

Products help prevent and improve peristomal skin conditions in ostomy patients
  ConvaTec (Skillman, NJ) Moldable Technology™ Skin Barriers can help prevent skin complications in ostomy patients by molding to the shape of the stoma and eliminating gaps for a more precise skin cover and protection. A study involving 700 patients who had ostomy surgery showed that 90% of patients with pre-existing skin conditions had normal skin after using this technology, while 95% of patients overall showed improvements in skin integrity.

  The skin barrier is designed to fit desired stoma size and shape, with no cutting necessary, and minimizes leakage with side swelling or “turtlenecks” up the stoma wall.

  For more information, visit www.convatec.com.

 Offloading boot prevents heel pressure ulcers in post-hip fracture patients
  A randomized control trial conducted in the fracture trauma unit of a major tertiary referral center in Belfast, Ireland, enlisted the use of Heelift® Suspension Boot from DM Systems (Evanston, IL) to compare the differences between complete offloading and standard care in the prevention of heel pressure ulcers in post-hip fracture patients.

  Both the control group (119 patients) and the intervention group (120 patients) had pressure-redistributing support surfaces; only the intervention group was fitted with the study product on both lower limbs. The outcome measurement was the presence or absence of a pressure ulcer (PU) classified as a National Pressure Ulcer Advisory Panel (NPUAP) category or above at the point of censor (discharge, transfer, or death).

  The findings showed that no patients in the intervention group developed a PU on their ankles, feet, or heels, whereas 29 subjects in the control group developed PUs in the same areas. The conclusion was that offloading devices such as the study product reduce the incidence of heel ulcers when compared to standard care pressure-redistribution surfaces.

  For more information, visit www.heelift.com.

PRP gel improves healing of complex chronic wounds
  AutoloGel™, a product of Cytomedix, Inc (Gaithersburg, MD), is an enhanced formulation of a near-physiological concentration of PRP gel that provides quick and consistent improvement in healing chronic wounds.

  A retrospective study was conducted using data from a multicenter registry consisting of a general chronic wound population of 285 wounds with previous average duration of 48.2 weeks treated at 39 health care facilities. Wound types included diabetic, pressure, or venous ulcers; dehisced, surgical, or traumatic wounds; and wounds of other etiologies.

  The study found that a positive clinical response occurred in 96.5% of 285 wounds in a mean of 2.2 weeks (range: .04—11) with an average of 2.8 PRP gel treatments (range: 1—7). Improvements were reported in area and depth reduction; deeper wounds healed at the same rate as more shallow wounds; wound healing outcomes were consistent between Medicare beneficiaries and non-Medicare recipients; and wound healing outcomes were consistent between healthy and clinically ill patients and across different wound types.

  For more information, visit www.cytomedix.com.

Nonpowered negative pressure system to be sold throughout Canada
  Spiracur Inc (Sunnyvale, CA) received a medical device license from Health Canada permitting the company to sell its SNaP® Wound Care System (Smart Negative Pressure) throughout the country. The system weighs 2.2 ounces, and uses a silent, lightweight, nonpowered pump used to deliver negative pressure wound therapy. Patients can easily and discreetly fit the device under clothing, which may result in improved patient acceptance and compliance of the therapy.

  Patients using the system found they could work, perform normal daily activities, and sleep better compared to patients using the traditional electrically powered negative pressure system.

  For more information, visit www.spiracur.com.

Product shown effective in large diabetic foot ulcer trial
  Sanuwave, Inc (Alpharetta, GA) announced the results of the largest trial ever for diabetic foot ulcers. The 206-patient, randomized, double-blind, parallel group, sham-controlled, multicenter, 24-week pivotal clinical trial was designed to quantify the safety and effectiveness of four, 20-minute, noninvasive procedures with dermaPACE, delivered over a 2-week period.

  The results found that in the intent-to-treat (ITT) population, 36% of the study subjects achieved complete wound closure beginning at 20 weeks following initial application, compared with 23% of sham-control subjects (P = 0.047); in the efficacy evaluable (EE) population, 38% of the study subjects achieved complete wound closure beginning at 20 weeks, compared with 21% of sham-control subjects (P = 0.018). These results remained significant throughout the study at 24 weeks in the ITT population (P = 0.054) and the EE population (P = 0.022).

  Subjects treated with the study product achieved a significant increase in the rate of complete wound closure or ≥90% wound area reduction by or at 12 weeks (P = 0.016) and within 6 weeks following the initial study procedure; and consistently throughout the 24-week period, the study product significantly reduced the size of the target ulcer compared with subjects randomized to receive sham-control (P <0.05).

  Of the subjects who achieved complete wound closure at 12 weeks, the recurrence rate at 24 weeks was only 4.5% in the study product group compared with 20% in the sham-control group, and the rate of adverse events between the two groups showed no significant difference, and no issues regarding the tolerability of dermaPACE procedures were shown.

  The study product is based on shockwave technology and applies pulsed acoustic pressure waves on acute and chronic defects of the skin and subcutaneous soft tissues (eg, post-operative wound healing defects, post-traumatic wounds, deep partial thickness burns, decubitus ulcers, diabetic ulcers, arterial ulcers, and venous ulcers).

  For more information, visit www.sanuwave.com.

Saline irrigation alternative introduced at APIC 2011
  IrriMax® Corporation (Atlanta, GA), a developer and marketer of irrigation solutions, introduced its flagship product IrriSept® at the Association for Professionals in Infection Control and Epidemiology (APIC) 2011 Annual Conference. The product is the first and only FDA-cleared cleansing and debridement system containing 0.05% chlorhexidine gluconate (CHG) concentration. It has tested effectively against a variety of bacteria and fungi, including Staphylococcus and methicillin-resistant S. aureus, and provides an alternative to saline irrigation. IrriSept O.R. can be used during surgical procedures as a final rinse before closure, or for existing surgical site infections (SSIs). The product can also be used on a variety of other wounds, including abscesses, skin and soft tissue infections (SSTIs), deep traumatic wounds, delayed closures, burns, wound dehiscence, and pilondial cysts.

  For more information, visit www.irrisept.com.

Industry News

Evidence-based practice center receives funds to carry out comparative effectiveness research on wound care
  The Agency for Healthcare Research and Quality (AHRQ) awarded the Johns Hopkins Evidence-based Practice Center (Baltimore, MD) a $475,000 project to research effective chronic wound care treatments. Researchers at the center will conduct a comparative effectiveness research, which includes compiling and analyzing evidence from existing clinical trials, clinical studies, literature, and research about chronic wound care, to supply healthcare providers and patients with evidence on the effectiveness, value, benefits, and risks of various treatment options.

  The researchers will prepare a scientific report to inform healthcare providers about effective state-of-the-art wound care that they hope will help patients make informed decisions about the right treatment plan for each wound.

  For more information, visit www.jhsph.edu/epc.

Appointments help progress strategic growth plan
  RecoverCare LLC (Louisville, KY) recently appointed two members to its senior management team. Mary Zappone, former president of Alcoa’s Oil & Gas unit, has been named President, while Larry Kramer, previously the Group Vice President Sales at AmerisourceBergen Corporation, will fill the role of Executive Vice President. The two combined have more than 50 years experience in management and healthcare sales and marketing.

  RecoverCare, a leader in wound care, bariatric, and safe patient handling equipment, looks to advance in two expanding markets: long-term care to the growing aging population and care for increasing numbers of obese patients. As part of this goal, the company recently introduced the VitalGo Total Lift Bed™, the only hospital-grade bed that takes a patient from lying to a fully standing position with no lifting by the caregiver. In addition to new product development, Zappone and Kramer will spearhead new employee career-path initiatives and customer training programs, to take off in the coming year.

  For more information, visit www.recovercare.com.

Chief financial officer named
  SteadMed™ Medical, LLC (Fort Worth, TX) announced the addition of Yon Choi as chief financial officer. With 16 years of experience, Choi will handle the company’s financial plan, budget maintenance, internal control compliance, internal and external audit reporting, and overall strategic financial support. Choi previously held positions at Galderma Laboratories, L.P. and Texas Instruments, including controller, director of finance, and vice president of finance.

  For more information, visit www.SteadMed.com.