New Products and Industry News
Continence control device is safe and effective
An international Phase 3 clinical trial of Vitala™ Continence Control Device (CCD), a product of ConvaTec (Skillman, NJ), has found the device to be safe and effective at restoring continence when worn up to 12 hours per day by people with a colostomy. The noninvasive device allows individuals to manage their colostomy without having to wear a pouch or incorporate irrigation.
The product prevents the uncontrolled release of stool stored inside the body, while permitting gas to vent through an integrated, deodorizing filter. The low-profile design also helps reduce noise and odors and helps make the ostomy less noticeable. The Phase 3 clinical study, conducted at 16 centers in the US and Europe, evaluated the safety and efficacy of the device when worn up to 12 hours by individuals (n = 78) with an end colostomy for nearly 6 months. Participants were monitored across a range of treatment stages, including usual pouching (21 days), skin barrier transition (14 days), and device wear (21 days of device ramp-up increasing to 12 hours of daily wear for 159 days).
After the study period of 215 days, results showed no serious adverse events related to wearing the device. No changes to stoma vascularity or gut microbiology were observed throughout the device wear stage.
The majority of participants in the study found the device easy to apply (76%), remove (99%), and dispose of (100%). More than four out of five users (83%) reported fewer odors than their usual device and three out of five (60%) said they experienced no noise while wearing the product. The device was also reported to be comfortable by 94% of participants and its profile acceptable by 77% of participants. At the end of the study, approximately 70% of participants, who had used traditional pouching systems on average for more than 6 years, said they preferred the device to their usual pouching system.
For more information, visit www.convatec.com.
Skin care lotions help maintain moisture balance
Covidien (Mansfield, MA) launched the Kendall™ Skin Wellness System, a comprehensive line of barrier creams, lotions and cleansers. This portfolio of seven formulas for skin cleansing, moisturizing, protection, and treatment helps restore the skin to its natural, healthy state.
Moisture balance is essential to skin health; skin that is excessively wet or dry is particularly susceptible to injury and infection. The products contain active pharmaceutical ingredients and jojoba, a natural plant oil often used in cosmetics that is easily absorbed by the skin and helps replace moisture when the skin’s natural oils have been diminished. For more information visit, www.covidien.com/skinwellness.
Hyperbaric chamber sold through medical equipment distributor in former Soviet republic
Environmental Tectonics Corporation’s Systems Group (Southampton, PA) has contracted with an undisclosed medical equipment distributor in a former Soviet republic for the delivery and installation of two BARA-MED XD monoplace hyperbaric chambers.
The chamber offers an increased tube diameter, accom¬modating patients up to 700 lb. Its optimized chamber size additionally lowers operational costs and improves clinical efficiency by offering a lower oxygen consumption rate.
Provided standard with the company’s software and the curvilinear compression protocol, the monoplace hyperbaric chamber will enhance patient comfort by reducing incidences of barotraumas by 67%, and increasing the probability that the patient will complete all treatment sessions as prescribed.
For more information, visit www.etchyperbaricchambers.com.
Chlorhexidine gluconate (CHG) adhesive delivery system tested
Tests conducted by an independent laboratory for Avery Dennison Medical Solutions (Chicago, IL) confirm that the company’s chlorhexidine gluconate (CHG) adhesive delivery system (ADS) provides antimicrobial efficacy across a broad range of bacteria and yeast. These data demonstrate that the challenge of incorporating CHG within a solvent acrylic adhesive has been successfully addressed. The new CHG ADS is trans¬parent and allows an access or incision site to be seen, a critical parameter for vascular access and postop dressings. The formulation will ultimately lend itself to use as a transparent film dressing that will make it easier to monitor sites such as catheter insertions.
In cytotoxicity tests, the company’s CHG ADS formulation outperformed two commercial products containing CHG by exhibiting a grade 0 cytotoxicity profile, compared with a grade 3 profile for the two commercial formulations.
These preliminary tests show that the new CHG ADS may be appropriate for applications where the spread of infection is a concern and moisture management and transparency are required, such as the securement of IV catheters, surgical incision films, and postop dressings.
For more information, visit www.medical.averydennison.com.
Medical Director named to Haiti wound program
John Macdonald, a former president of the Association for the Advancement of Wound Care (AAWC), has been named the Medical Director of the wound program at Project Medishare and Hospital Bernard Mevs in Port-au-Prince, Haiti.
Project Medishare is a non-profit organization committed to providing quality healthcare to the citizens of Haiti.
The active wound care program is the continuation of a post-earthquake program created in January 2010 by the Department of Dermatology and Cutaneous Surgery, Miller School of Medicine, University of Miami.
The program establishes a unique wound care initiative that allows direct interaction between a developing nation program and a university academic center.
Macdonald will continue to be involved with the World Alliance for Wound and Lymphedema Care.
FDA grants 510(k) clearance for silver advanced wound care products
MediPurpose® (Atlanta, GA) received 510(k) clearance from the US Food and Drug Administration (FDA) to market its MediPlus™ foam wound care products that contain antibacterial silver. The company’s advanced wound care product portfolio now includes Foam Ag, Comfort Foam Ag, and Super Foam Ag dressings. The new dressings meet the latest standards for anti¬bacterial control established by the FDA and provide an effective barrier to bacterial penetration. The silver foam dressings are indicated for use on a wide range of chronic and traumatic wounds that included ulcers (arterial, dia¬betic, pressure, and venous), donor sites, surgical incisions/ excisions, and first- and second-degree burns.
The products are expected to be available in the fourth quarter, and information for requesting pricing and samples is available online.
For more information, visit www.medipurpose.com.
Medical devices company signs with group purchasing organization
SteadMed® Medical, LLC (Fort Worth, TX), a healthcare company that provides medical devices and products, recently signed a contract with MedAssets (Atlanta, GA), a leading group purchasing organization for healthcare providers.
This contract gives MedAssets access to Drawtex®, a patented hydroconductive, nonadherent wound dressing with LevaFiber™ technology. The contract will also support SteadMed’s Elta® products.
For more information, visit www.SteadMed.com.
International symposium on pediatric wound care to be held in October
The First International Symposium Pediatric Wound Care (ISPeW) will be held October 27-29 at the Pontifical University of St. Thomas Aquinas (Rome, Italy).
Topics related to neonatal and pediatric wound care will be discussed, including chromosomopathies, genetic disturbances, neurological impairment, war lesions, and animal bites.
For more information, visit www.ispew.eu.
Wound care distribution company names new CFO, Vice President - Human Resources
RecoverCare LLC (Louisville, KY), a distributor of wound care, bariatric, and safe patient handling equipment to healthcare facilities nationwide, announced the appointments of Kevin S. Boyle, Sr. to Chief Financial Officer (CFO) and Rodney Vinegar to Vice President-Human Resources. These appointments signal the company’s continued focus on fortifying its senior management team to support its growth on multiple fronts.
A recognized leader in capital markets, strategic finance, and management, Boyle has diverse professional experience working with both public and private companies. Before joining the company, Boyle was CFO for SPT Inc. (Houston, TX), a marine transportation and services company, and he also held senior management positions at American Commercial Lines, Great Lakes Transportation, and Seabulk International.
Vinegar brings an extensive breadth of human resource management experience to his post. During his 16-year professional career, he has been responsible for recruitment, training, professional development, diversity strategies, and change leadership within global companies. In 2011, he served as Senior Vice President of Human Resources at the media company Scripps Networks. He sits on the Board of Directors of the Workforce Professional Training Institute, a New York City-based non-profit dedicated to strengthening the capability of managers for non-profits.
For more information, visit www.recovercare.com.