New Products and Industry News
Educational skin care booklet released
Healthpoint (Fort Worth, Tex.) announced the availability of a new educational booklet for patients with a variety of dry skin conditions. The booklet provides tips for managing and coping with the chronic skin conditions. Millions of Americans suffer from hyperkeratotic skin conditions characterized by thickening of the skin, dryness, roughness, itching, burning, scaling and raised red patches.
In a related action, the company also recently introduced Salex™Cream, a topical prescription medication used to treat conditions such as ichthyosis, keratosis pilaris, and psoriasis. The cream helps minimize friction while hydrating and lubricating affected areas of the skin. The cream also loosens dry skin and scales.
For more information, call (800) 441-8227 or visit https://www.healthpoint.com.
Larger size moisturizer available to help meet CMS surveyor guidelines
Coloplast (Atlanta, Ga.) announced the release of a larger 9-oz. size Sween® 24, a routine, long-lasting, once-a-day moisturizer for dry, flaky skin associated with xerosis. Dry, winter climate is just one of many risk factors that contributes to xerosis. Other risk factors include aging skin, non-pH balanced skin cleansers and other disease states. A proper skin assessment is a crucial intervention in pressure ulcer development, as suggested by the new CMS surveyor guideline for long-term care facilities.
Because this product requires only one application per day to continuously moisturize patients’ skin, nursing time is minimized while protocol compliance is maximized.
The company also has made its Skin The Vital Organ® Skin Assessment Tool available to help document a full skin assessment and meet the requirements of CMS.
Visit https://www.us.coloplast.com for more information.
Improved website now online
Swiss-American Products Inc. (Dallas, Tex.), manufacturer of the Elta brand of specialty skin and wound care products, has launched a new and improved website — https://www.elta.net. Updates have been designed to provide additional product information, including features and benefits, MSDS (Material Safety Data Sheets), and an easy-to-use retail locator search.
Products have been organized into groups, including moisturizers, sun care, wound care, enzyme-enhanced, continence care, massage therapy, and psoriasis and eczema. Each section provides a list of categorized Elta products and provides a link to a page with details about each product.
Web users also may utilize the search function to locate retailers in their area that carry Elta products as part of their regular skin care offering. By entering a zip code or postal code (for Canadian users), the user may find a list of stores where Elta products may be purchased.
Licensure agreement reached
Helix BioMedix (Bothell, Wash.) announced that it has signed a memorandum of understanding with Smith & Nephew (Largo, Fla.), which gives Smith & Nephew a right of first offer to license certain rights to a number of wound-related indications for HB50, a Helix BioMedix proprietary peptide. In return, Smith & Nephew agrees to provide input on the pre-clinical and clinical development the product as a topical anti-infective for use in wound care. Under the terms of the memorandum of understanding, Smith & Nephew will be providing wound management expertise to the Helix BioMedix development team throughout the development process.
The peptide’s attributes include broad-spectrum activity, lack of resistance induction, cost effective synthesis, stability, and activity against multiple antibiotic-resistant pathogens. In pre-clinical testing, HB50 in a gel formulation has been shown to significantly reduce the numbers of Staphylococcus aureus in an abraded skin infection model and, in the majority of cases, eradicates the organism. In addition, with activity against other Gram-positive and -negative bacteria such as Pseudomonas aeruginosa, the peptide also has application in the areas of burn wounds and dermatology.
For more information, visit https://www.helixbiomedix.com.
Venous stasis ulcer clinical trial initiated in Europe
RegeneRx Biopharmaceuticals Inc. (Bethesda, Md.) announced the beginning of a Phase II clinical trial to test its drug Thymosin beta 4 (TB4), for the treatment of venous stasis ulcers. The Phase II trial will be a randomized, double-blind, placebo-controlled trial designed to test several dosages of TB4 in patients with venous stasis ulcers in Italy and at least one other European country. The drug will be administered topically to each patient over a period of several weeks. The study is scheduled for the second quarter of 2005 and should be completed and analyzed within approximately 1 year from enrollment of the first patient.
This trial is the second in a portfolio of complementary clinical trials planned by the company designed to evaluate TB4’s effect on wound healing for specific types of dermal and ocular wounds.
Visit https://www.regenerx.com/home.htm for more information.
Walking boot unloads limb and promotes healing
Swede-O (North Branch, Minn.) introduced a new patient-friendly Walking Boot designed for use with severe ankle sprains, stable ankle fractures, and post-cast removal and surgery. The boot uses a rounded “rocker bottom” sole and lightweight construction to partially unload the limb to help promote healing. The boot is available in tall and short versions and is anatomically contoured with a deluxe foam liner for a better fit and patient stability. The cushioned heel is designed for greater energy absorption and has a wider foot bed to accommodate various patient foot sizes.
The boot will fit men’s shoe sizes 4-13.5 and women’s sizes 5-14.5.
For more information, email info@swedeo.com or visit https://www.swedeo.com.
FDA gives clearance to initiate diabetic foot ulcer trial
Ortec International Inc. (New York, NY) announced that the US Food and Drug Administration (FDA) has completed a review of the modified Diabetic Foot Ulcer (DFU) Protocol submitted to the FDA on January 6, 2005 and has given the company permission to initiate a pivotal trial evaluating OrCel® in the treatment of diabetic foot ulcers. The company expects to initiate patient enrollment shortly after receiving approval of its Premarket Approval (PMA) application for the use of the product in the treatment of venous leg ulcers (VLU) currently under FDA review. The DFU trial is expected to be conducted at up to 25 clinical centers and involve up to approximately 200 patients.
The results of the multicentered controlled pilot study assessing the effectiveness of its product in treating diabetic foot ulcers was featured in the July 2003 issue of the peer reviewed publication WOUNDS. The article was entitled, “Effectiveness of Bilayered Cellular Matrix in Healing of Neuropthathic Diabetic Foot Ulcers: Results of a Multicenter Pilot Trial.” You can access the abstract here.
For more information, visit https://www.ortecinternational.com.
WOCNCB launched new credential in January 2005 — Certified Foot Care Nurse (CFCN™)
In January 2005, the Wound, Ostomy and Continence Nursing Certification Board (WOCNCB) began to offer a new certification credential to registered nurses (RNs) who perform foot and nail care.
The WOCNCB is dedicated to providing consumer safety and protection by offering this new credential in the areas of foot and nail care nursing. Many RNs provide basic foot and nail care in long-term care facilities, home care agencies, and in acute care — some perform advanced procedures such as assessment of the lower extremity. Nursing interventions involve skin and nail care, patient education, and referrals based on abnormal assessment findings.
The WOCNCB surveyed nearly 1,500 RN professionals who provide foot and nail care. Based on the responses, the WOCNCB proceeded with the development of test specifications that could lead to a certification examination.
