Surgery News - November 2007 - (Page 7)

NOVEMBER 2007 • SURGERY NEWS DRUG DEVELOPMENTS Manuka honey has been found to be active against a broad spectrum of organisms— fungi, anaerobic and aerobic bacteria, and gram-negative and gram-positive bacteria. Dr. Molan said he has no financial ties to Derma Sciences. Dr. Jean DeLeon, medical director of wound care at Baylor Specialty Hospital, Houston, said she believes honey-based wound dressings have great potential and “could, without adding too much cost to our health care system, help us treat wounds and reduce resistant bacteria.” What is needed before they are used more widely, however, are randomized clinical trials, “to help us make good decisions as 7 NEW INDICATIONS & APPROVALS Taxotere, Medihoney Wound Dressings Taxotere Injection Concentrate (docetaxel, Sanofi-Aventis) An antineoplastic agent approved for use in combination with cisplatin and fluorouracil for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN), prior to chemoradiotherapy and surgery; approved in 2006 for inoperable, locally advanced SCCHN, in combination with cisplatin and fluorouracil. Recommended Dosage: The threedrug regimen administered every 3 weeks for three cycles, followed by chemoradiotherapy. Special Considerations: Infections, neutropenia, anemia, thrombocytopenia, nausea, vomiting, and alopecia are among the most common adverse reactions associated with treatment. Comment: Approval was based on an open-label, multicenter study of 501 patients with locally advanced SCCHN. Patients had stage III or IV SCCHN, with no distant metastases, and were treated every 3 weeks for three cycles with the threedrug combination, or with standard twodrug therapy, followed by chemoradiotherapy for 7 weeks for those who did not have progressive disease and then surgery for patients considered candidates. Median overall survival was 70.6 months for those randomized to Taxotere, and 30.1 months for those who received cisplatin and fluorouracil alone. The finding that Taxotere was beneficial in this group of patients adds another treatment to the armamentarium for head and neck cancer, said Dr. James Neifeld, professor of surgical oncology at Virginia Commonwealth University, Richmond, Va. These patients often present with advanced disease, he said, adding that surgical treatment is associated with major complications and loss of organs. Dr. Neifeld was not an investigator in the study. Medihoney Dressings (active Manuka honey absorbent dressing, Derma Sciences Inc.) A honey-based wound dressing that “provides a moist environment conducive to wound healing,” indicated for moderate to heavily exuding wounds such as diabetic foot ulcers, leg ulcers, pressure ulcers/ sores, and first- and second-degree partial thickness burns, in addition to donor sites as well as traumatic and surgical wounds, according to the Food and Drug Administration’s clearance of the product. This is the first honey-based dressing to become available in the United States. Special Considerations: Cleared by the FDA in June, the product is now available for physicians to order according to a Derma Sciences spokesperson. Comment: If a manufacturer can show that a device is “substantially equivalent” to similar devices that are legally marketed for similar indications, the FDA clears the device for marketing. The dressing contains Leptospermum honey, derived from the nectar of the Manuka bush that is indigenous to New Zealand. Manuka honey has been used for medicinal purposes for centuries by New Zealanders. In Europe, honey-based products compete with silver-based dressings, according to Derma Sciences. Peter Molan, Ph.D., director of the honey research unit and professor in biological sciences at the University of Waikato, Hamilton, New Zealand, said the basis of honey’s antibacterial activity is the antiseptic effect provided by hydrogen peroxide that is produced when bees add an enzyme to the nectar when it is collected. to when to use this type of topical dressing, versus some of the other dressings we are already using as our standard of care,” she said. Dr. DeLeon said she has not used any honey-based product on patients, but is familiar with the use of honey as a wound-healing treatment, and with the related data, largely anecdotal evidence from many small clinical studies in Europe. The studies have produced positive results data—including evidence that honey can reduce even resistant bacteria in wounds— that she said are “very hard to ignore.” Dr. DeLeon said she has no financial ties to Derma Sciences. —Elizabeth Mechcatie http://www.surgitel.com http://www.surgitel.com

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Surgery News - November 2007 Contents Black Patients Fare Worse Than Whites After Liver Surgery Survey Suggests Need For Acute Care Surgery New Law Bolsters FDA Funding, Authority Working Together Oncology: Marginal Evidence? Trauma: Screening Scrutinized News From the College: Healy Takes Helm

Surgery News - November 2007

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