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IN THE SPOTLIGHT

Age-Old Therapy Gets New Approval MAGGOT THERAPY AT WORK Photos show the foot of a 59-year-old man with diabetes who Kathleen A. Greer • Senior Editor • Advances in Skin & Wound refused amputation despite osteomyelitis. Maggot therapy debrid- ed his wounds, including the nonviable big toe; the remains of that Care • Ambler, PA toe were removed surgically. One and a half years later, he left the Last year, the Food and Drug Administration (FDA) gave facility with his foot fully healed. permission to market maggots as the first “live” medical device. In a recent interview with Advances in Skin & Wound Care, researcher Ronald Sherman, MD, MSc, discussed how maggot therapy can help wound healing and shared his thoughts on the future use of this age-old therapy. Dr Sherman is Assistant Researcher, University of California, and Director, BioTherapeutics, Education and Research Foundation (BTER), both in Irvine, CA.

Q: How do maggots help kill bacteria and stimulate granulation, as well as debride wounds? A: In January 2004, the FDA gave clearance to produce and market medical maggots for “debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.” In July 2004, our labora- tory at the University of California, Irvine, registered with the with the rapid growth of epithelial and granulation tissue in FDA as a production site for medical maggots. The FDA has vivo. Wound healing effects may also be due to the appar- not considered, nor approved, any claims of disinfection or ent increase in local perfusion and oxygenation that has growth-promoting properties. Nevertheless, there are both been recorded during maggot therapy. clinical and scientific studies that address the antibacterial and growth-promoting properties of maggots. Q: Are maggots used only in specialized wound centers? Debridement results when the maggots release their A: Medical maggots are used today in more than 300 sites potent proteolytic digestive enzymes into the wound bed. around the country, including specialized wound centers The wound bed is like a dinner table to maggots. These and tertiary care hospitals, specialized and general medical enzymes gain access to the deeper necrotic tissue through outpatient clinics, extended care facilities, private practition- the mechanical debridement action of the maggots’ ers’ offices, and even by visiting nurses who apply the mag- “mouth hooks”—2 probing appendages near their tooth- got dressings in patients’ homes. less mouth. Mixed with these enzymes—or perhaps directly as a result of some of these enzymes—many Q: In appropriate cases, is maggot therapy more cost- microorganisms within the wound bed are killed. effective for patients than traditional surgical procedures? Other infectious organisms are ingested by the maggots, A: No therapy should ever be selected purely on the basis of along with the partially digested necrotic tissue, and are cost. We are discussing maggots today because of their later killed within the maggot’s gut. These secretions have demonstrated efficacy, not simply their low cost. Never- been shown to stimulate cells in culture and are associated theless, cost-effectiveness is a part of any meaningful

Department Editor: Cathy Thomas Hess, BSN, RN, CWOCN

ADVANCES IN SKIN & WOUND CARE • VOL. 18 NO.1 12 WWW.WOUNDCAREJOURNAL.COM WCAN0105 01/28/05 4:43 AM Page 15 InInffooLLink

discussion of medical care. And the low cost of maggot ther- Corporation. The 3 new products are Advantage System, apy has often been touted as one of its major attributes. The designed for the placement of midurethral slings through few studies that have addressed the issue of cost indicate transvaginal delivery; Lynx System, designed for the place- that maggot therapy is, indeed, more cost-effective than ment of midurethral slings suprapubically; and Obtryx comparable standard surgical or nonsurgical treatments. System, designed for the placement of midurethral slings We are not in a position to quantify the cost savings, but through the transobturator approach. we can surmise that it must be substantial, based on 2 ▲ Information: http://www.bostonscientific.com observations. In Europe, where national, single-payer health care is the norm, maggot therapy has become an Silipos increasingly common practice. Approximately 30,000 maggot Explorer Pin and Cushion prosthetic suspension liners. treatments are administered annually in Europe. But there Silipos has introduced new design features to its popular has been less demand in the United States, where insur- Explorer Pin and Cushion tri-block polymer gel prosthetic ance coverage of maggot therapy varies. In fact, the US suspension liners. The liners now have a proprietary stabi- demand for medical-grade maggots has been too small to lizing matrix to reduce distal elongation during gait while support a single commercial supplier. Thus, the nonprofit maintaining distal conformity, BTER Foundation is subsidizing the production and patient even with irregularly shaped care costs through donations. residual limbs. Both liners The cost-effectiveness of maggot therapy is apparent to have a smaller, silk-screened many in the United States, however. Some hospitals tell me logo that cannot be felt by they prefer to pay for maggots from their own operating the patient or seen when budgets to cure wounds and discharge patients faster than placed in the socket. A to use more conventional, billable treatments. The major translucent urethane cap expense associated with maggot therapy is the labor- provides improved strength intensive cost of preparing the perishable maggots. And, it and flexibility. requires clinical time to secure dressings upon the wound. The liners are retrofittable only to Explorer sockets that Q: Do you believe maggots will be more widely used have the same gel thickness, for wound treatment in the near future? liner shape, and size. A: The use of maggot therapy will soon increase, just as it ▲ Information: http://www.silipos.com has in the rest of the world. In the United States, the demand for medical maggots has increased by about 20% INDUSTRY NEWS per year over the past 10 years. Since the FDA ruling last year, the demand has already doubled. The Food and Drug Administration (FDA) recently cleared the Versatile 1 Wound Vacuum System from BlueSky Medical, Selected References La Costa, CA, for marketing. The system applies localized Graninger M, Grassberger M, Galehr E, et al. Comments, opinions, and brief case reports: bio- negative pressure to the wound bed to promote healing. The surgical debridement facilitates healing of chronic skin ulcers. Arch Intern Med 2002; Centers for Medicare & Medicaid Services (CMS) has also 162:1906-7. Jukema GN, Menon AG, Bernards AT, et al. Amputation-sparing treatment by nature: “surgi- approved reimbursement of the Versatile 1 Pump and acces- cal” maggots revisited. Clin Infect Dis 2002;35:1566-71. sory kits. This will allow the company’s dealer base to use Sherman RA. Maggot therapy for treating diabetic foot ulcers unresponsive to conventional the assigned codes for Medicare reimbursement purposes. therapy. Diabetes Care 2003;26:446-51. ▲ Information: http://www.blueskymedical.com Sherman RA. Maggot vs conservative debridement therapy for the treatment of pressure Wright Medical Group, Inc ulcers. Wound Repair Regen 2002;10:208-14. , Arlington, TN, has received Sherman RA, Shimoda KJ. Presurgical maggot debridement of soft tissue wounds is asso- reimbursement approval from the CMS for 2 of its wound ciated with decreased rates of postoperative infection. Clin Infect Dis 2004;39:1067-70. care products. The GRAFTJACKET Ulcer Repair Matrix Wollina U, Liebold K, Schmidt WD, et al. Biosurgery supports granulation and debridement in will have code “C9221,” and code “C9222” is assigned to chronic wounds—clinical data and remittance spectroscopy measurement. Int J Dermatol GRAFTJACKET XPRESS Flowable Soft-Tissue Scaffold. 2002;41:635-9. GRAFTJACKET’s Ulcer Repair Matrix is designed to allow healing at deeper levels, while protecting the external NEW PRODUCT NEWS layer of the wound with a graft material that converts into functional host tissue. The GRAFTJACKET XPRESS Flowable Soft-Tissue Scaffold can be administered easily Boston Scientific Corporation through a syringe to quickly fill the voids in the wound, cre- Midurethral sling products. A full line of midurethral ating a barrier against infection and providing a bioactive sling products for the treatment of stress urinary inconti- scaffold to aid in tissue formation. nence in women has been launched by Boston Scientific ▲ Information: http://www.wmt.com

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