NEWS BRIEFS
July 1, 1999 4 minutes read
NEWS BRIEFS
Composite Cultured Skin is in clinical trials on donor site wounds
Ortec International, a New York-based tissue engineering company involved in the development of proprietary and patented technology to stimulate the repair and regeneration of human tissues, has patented a biologically active wound dressing, Composite Cultured Skin (CCS), consisting of a bioengineered bovine collagen matrix seeded with epidermal and dermal cells. CCS is in clinical trials for treatment of donor site wounds and venous skin ulcers and has completed a clinical trial using CCS for treatment of chronic dermal skin ulcers in epidermolysis bullosa patients.
Ortec says CCS also may have wide commercial applications for the treatment of burns, as well as diabetic and venous skin ulcers. The results of an eight-patient pilot trial conducted on burn patients at the Columbia Augusta (GA) Medical Center were presented at the American Burn Association (ABA) by Joseph Still, MD, director of the burn center at Columbia Augusta.
Results showed that CCS closed the donor site wounds in all eight patients treated an average of 9.5 days earlier than did the control dressing. Donor site wounds are created when healthy skin is taken from an undamaged part of the patient’s body and transplanted onto an existing wound site, thereby creating an additional wound at the donor site. These procedures are called autografts. Treatment of donor site wounds has particular application to burn victims and reconstructive surgery patients.
CCS clearly promotes wound healing in select deep second- and superficial third-degree burns, without the need for autograft, Still says, and "has shown almost 100% re-epithelialization in 11 days after application on donor sites, demonstrating the potential to significantly accelerate wound closure in this patient population, which means we can re-operate shortly thereafter using the patient’s own skin. I believe CCS has the potential to significantly increase the survival rate of severely burned patients and play a significant role in the burn arena."
The company has submitted the results of this pilot study to the FDA, and, based on these results, has requested permission to begin a pivotal trial using CCS in donor sites. The proposed study would involve following 75 patients for six months, with a primary end point of comparing the time to wound closure using CCS vs. the standard of care, and secondary end points measuring scarring, pain, rate of infection, time to recropping, and any adverse events. After the requisite follow-up, a pre-market application will be filed with the FDA.
For further information on Composite Cultured Skin, contact: Ortec International, 3960 Broadway, New York, NY 10032. Telephone: (212) 740-6999. Fax: (212) 740-6963.
Wound Product Sourcebook now available
The Wound Product Sourcebook contains information for every type of wound care product, ranging from dressings and skin care to support surfaces and training programs. Edited by Glenda J. Motta, BSN, MPH, ET, it is arranged in an easy-to-read format that includes product description, sizing, specifications, and manufacturer. It also lists products by trade names and gives toll-free telephone numbers for manufacturers.
The 1999 edition is now available for $69.95 from Green Mountain Wellness Publishers, P.O. Box 554, Hinesburg, VT 05461. The Wound Product Sourcebook also may be ordered on-line at www.woundsource.com.
The sourcebook staff process submissions for product and professional resource listings throughout the year and immediately post them on their Web site. To submit listings for inclusion in the Wound Product Sourcebook and WPS on-line, please contact the publisher at (802) 862-1265 and request a forms packet.
Wound care software available from KCI
Kinetic Concepts, Inc. (KCI), a San Antonio-based company that develops and markets therapeutic healing systems for problems associated with patient immobility, now is also marketing a comprehensive wound management software program called Odyssey. The company says the program will track: outcome of prevention and treatment modalities for wounds; compliance with the standard of care/protocols for the prevention and treatment of wounds; progression of the wound toward healing; and the use of surfaces, topical treatments, and other interventions. The program, which is available for $295 per year, also helps standardize documentation, tracks costs, and, with a sufficiently large database, allows a facility to predict treatment outcomes and create clinical critical paths based on the data entered about wounds treated in the facility. A 30-day evaluation disk is available for program trial.
For further information on Odyssey, contact: KCI, 8023 Vantage Drive, San Antonio, TX 78230. Tele phone: (210) 524-9000.
AHCPR provides free guidelines on Internet
The Agency for Healthcare Policy and Research (AHCPR) offers a free Internet database of clinical practice guidelines. The American Medical Association and the American Association of Health Plans worked with AHCPR in developing a clearinghouse that offers evidence-based guidelines presented with standardized abstracts and tables.
For more information, contact AHCPR at 2101 E. Jefferson St., Rockville, MD 20852. Telephone: (301) 594-6662. Web site: www.guideline.gov.
Find your best practices and national guidelines on the Web
The Best Practices Network (BPN), an interactive Web site directed by Mary Kingston, RN, MN, provides an opportunity for health care professionals to share information about their projects and best practices. The Web site, the use of which is free, allows health care professionals to put their evolving project ideas on-line and participate in discussion boards for clinical practice, professional practice, documentation, and system issues.
The Everyday Innovations section of BPN’s Web site includes tools that can be downloaded and used, including the project guide and application kit, which is designed to improve health care delivery.
For more information, contact BPN at its Web site, www.best4health.org., or call (800) 899-2226.
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