Copyright @ Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. Maggot Therapy for Problematic Wounds: Uncommon and Off-label Applications Ronald A. Sherman, MD, MSc; Charles E. Shapiro, MD, FACS; and Ronald M. Yang, MD Seventy years ago, maggot therapy was used by more than 1000 surgeons in North America. 1 More than 90% of them were satisfied with these wriggling surgical assistants. At that time, maggot therapy was most often used for controlling soft tissue infections and as an adjunct to surgical resection for osteomye- litis. 2 One or 2 days following surgical debridement—or as soon as bleeding was controlled—maggots would be placed within the wound to accomplish any necessary fine debridement, control infection, and facilitate healing. Maggot therapy all but disappeared during the 1940s, with the advent of modern antibiotics and improved surgical techniques. But it is now making a comeback. 3 This year, an estimated 50,000 bottles of medical-grade maggots will be distributed by 12 laboratories to patients in 20 countries. In 2004, Medical Maggots (Monarch Labs, Irvine, CA) be- came the first live animal to be cleared for marketing in the United States by the Food and Drug Administration (FDA). 4 Approved indications are for debriding nonhealing necrotic skin and soft tissue wounds including pressure ulcers, venous ulcers, neuropathic foot ulcers, and nonhealing traumatic or postsurgical wounds. 5 These were the uses for which efficacy and safety data were available, and they remain the most common applications of maggot therapy today. 6–14 However, maggot therapy was used in wound care long before the FDA marketing clearance, and some of its appli- cations have been outside these specific indications. It was hypothesized that there may now be frequent off-label uses of maggot therapy. If this is true, there may be a need to evaluate the safety and efficacy of maggot therapy for such indications. To explore this hypothesis, the authors describe their own off- label experience and that of other surveyed clinicians. METHODS Survey Participants and Case Selection Between 1990 and 1995, 101 wounds in 70 patients were treated with maggot therapy at the Veterans Affairs Medical Center in Long Beach, CA, and the University of California Irvine Medical Center in Orange, CA. Most of these individuals had pressure ulcers or diabetic foot ulcers, and their outcomes were reported elsewhere. 6,7 Larvae were also distributed to more than 500 hospitals and wound care centers. In 2005, approximately 350 of those clinicians were asked to complete a brief survey describing the indications for which they used the treatment. Invitations and surveys were distrib- uted with the BioTherapeutics, Education and Research (BTER) Foundation newsletter 15 to nearly 400 therapists. The survey ADVANCES IN SKIN & WOUND CARE & VOL. 20 NO. 11 602 WWW.WOUNDCAREJOURNAL.COM ORIGINAL INVESTIGATION Ronald A. Sherman, MD, MSc, is Assistant Researcher, Department of Pathology, University of California; Director, BioTherapeutics, Education & Research Foundation, Irvine, CA; and Medical Director, Monarch Labs, Irvine, CA; Charles E. Shapiro, MD, FACS, is Chief, Department of Urology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA; and Ronald M. Yang, MD, is Surgical Resident, Department of Urology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA. ABSTRACT OBJECTIVE: To identify off-label uses for maggot therapy that may be worthy of further clinical evaluation. DESIGN: Clinician surveys and invitations to submit unusual and off-label uses of maggot therapy. SETTING: All levels of inpatient, outpatient, extended care, and home care. PARTICIPANTS: More than 350 clinicians known to use maggot therapy were invited to participate in the survey. Twelve returned the survey. MAIN OUTCOME MEASURE: Indications for maggot therapy other than simple debridement of wounds listed on product labeling. MAIN RESULTS: A total of 544 wounds were treated by the 12 respondents; 131 (24%) were rare or off-label applications, including stimulation of epithelialization in clean but nonhealing wounds; disinfection, odor, and drainage control; determination of tissue viability; debridement of acute burns, necrotic tumors, and ischemic ulcers; and debridement of unusual sites (ie, glans penis, joints, pleural space, and peritoneal cavity). Noted drawbacks included the time and effort needed to train personnel and convince administrators of the need for treatment. CONCLUSION: Medicinal maggots are frequently being used as an adjunct to other methods of surgical and nonsurgical wound care and often for off-label indications, including debridement, disinfection, and stimulation of healing. Further study is warranted to evaluate the efficacy and safety of maggot therapy for these indications, and better education is needed for administrative and clinical staff to make maggot treatment more accessible. ADV SKIN WOUND CARE 2007;20:602–10