Storage & Handling - $Medical should not be allowed to structures usually require surgical and/or Medical Maggots™ Upon arrival, Medical Maggots should be remain in the when they are dead; for antibiotic treatment as the primary therapy inspected for activity; any problems they may trigger an allergic response or may (with or without adjunctive maggot therapy). Description and Natural History - must be reported to the manufacturer become the nidus for further infection. $Maggot therapy should never be used to treat immediately (contact information listed below). $After use, handle Medical Maggots as you which are not directly exposed to the Each vial of Medical Maggots contains outside (for example, abscesses not incised Medical Maggots should be used within 24 would other infectious dressing waste. Used approximately 1,000 Phaenicia. (=Lucilia) and drained). Wounds should never be hours of receipt (preferably on the day of arrival) maggot dressings should be double-bagged sericata (blow ) eggs, from which 250 - 500 allowed to close over the to ensure sterility and optimal viability. Do not (contained within a sealed plastic bag, which Medical Maggots maggots will normally hatch within 12 hours of use if “sterile” cap seal is broken or missing. is completely contained within a second either intentionally or unintentionally. preparation. Each vial also contains 2"x2" gauze This is a “single use only” item. The vial is not sealed plastic bag) to ensure that the maggots $Use of Medical Maggots is contraindicated and sterile food (containing soy protein and designed for multiple dosing, and the maggots do not escape. in patients whose circulatory integrity is brewer’s yeast). Many of the Medical Maggots may not be applied more than once. “Used” $Beware: Medical Maggots may try to escape compromised to the extent that the wound will be in the gauze pad and difficult to see; maggots must be handled as contaminated from the dressing, especially when they have ultimately has minimal chances of healing. In others will be crawling along the sides of the vial medical waste; unused maggots must be debrided all necrotic tissue or when they are such circumstances, maggot therapy is likely (especially when the vial is warmed), and can be destroyed [see Disposal and Restrictions and satiated (finished eating). Medical Maggots to enlarge the wound as it is debrided, removed easily by wiping them off the sides of Disclaimers, below]. should not be used on more than one patient, removing necrotic tissue and debri, but the vial with a 2"x 2" gauze pad moistened with nor allowed to wander away from their host leaving the patient with a wound which will sterile saline or water. again succumb to advancing infection. Warnings - patient. Once they have been applied to a $Mild bleeding is common during maggot $ Patients allergic to fly larvae, brewer's yeast, patient, they must be considered as fomites. P. sericata eggs are yellow, rice-shaped, 2 mm debridement, and it is common that the or soy proteins may manifest allergic Escaping maggots have been known to upset long. After hatching, the egg shells will turn wound drainage is blood-tinged. Patients with reactions to Medical Maggots which are the hospital staff and/or patients. If not brown, soft, and ultimately dissolve. The newly properly disposed, escaped maggots could natural or pharmacologically induced hatched larvae are 2 mm long, and translucent prepared in such media. Special preparation coaggulopathies are at risk of significant and media is available upon request. pupate and mature to adult white. Young P. sericata larvae feed upon approximately two weeks later. bleeding during maggot therapy. Maggot $ Medical Maggots can cause pain or necrotic tissue and wound fluids. The maggots $During the first application, and whenever therapy in such individuals, if done at all, discomfort, particularly in patients already release their digestive enzymes into the local problems with infection, pain or dressing should be done under close supervision. experiencing wound pain. Maggot-associated environment, and ingest the liquefying and semi- integrity are likely, the maggot dressings $Maggot debridement of, or around, necrotic pain or discomfort usually manifests at about solid tissue. As they grow, they molt twice. In should be inspected daily until removed. blood vessels can lead to rupture of those 24-36 hours into therapy, and increases as the nature, the maggots would leave their food $See also Contraindications and Dosage and blood vessels, which could be life- larvae grow larger. If systemic analgesics do source when satiated, and burry themselves in a Administration. threatening. Use of Medical Maggots in not control the pain, then remove the maggot suitably protected area. There they would pupate that situation is contraindicated. If maggot in relative safety. Adult flies emerge (eclose) dressing to achieve immediate pain relief. Do Contraindications - therapy is attempted, the patient must receive approximately 10-20 days later. Developmental not apply local anesthetics (i.e.: lidocaine) to close, continuous, intensive observation for times are temperature-dependent. the wound while Medical Maggots are in $Patients allergic to fly larvae, brewer's yeast, or soy bean protein may manifest allergic bleeding, vascular rupture, infection, or place. thrombosis. reactions to Medical Maggots, which are Mechanisms of Action - $Every batch of Medical Maggots is cultured $ should not be given prepared in such media. Patients allergic to Medical Maggots Debridement results partly from the Medical during production to ensure sterility; but unlimited access to deep organs and tissues contamination through the delicate air- the other maggots dressing materials also may Maggots proteolytic digestive enzymes when such access could disrupt important permeable vial can occur later during manifest contact dermatitis or more serious liquifying the necrotic tissue and partly from the neurovascular structures or intact sterile handling, shipping, storage, or any time the immunologic reactions. Patients with serious physical action of the mouth hooks on the tissue, cavities. vial is opened . Medical Maggots should not allergic reactions should not be treated with which pierce and tear the necrotic tissue, $Medical Maggots should never be introduced be used if the sterile seal is broken, if the filter Medical Maggots, or should be treated in allowing the digestive enzymes to reach the into sterile body cavities; they are is damaged, if the maggots have a strong such a way as to avoid all contact with the depths of the necrotic tissue. contraindicated for use in eyes, upper offensive odor, or if they are known or offending antigens. If treatment is undertaken, gastrointestinal tract, or respiratory tract. suspected of being contaminated. The vial of then it should be done only with close $Pseudomonas aerugenosa wound infections Medical Maggots is not intended for multiple attention and immediate access to care. may not be controlled maggot therapy alone. Clinical Indications: dosing. $Patients with acute, rapidly advancing, life- or Specific anti-pseudomonal therapy may be Medical Maggots and maggot debridement $Wounds should never be allowed to close over limb-threatening infections should not be needed during, or before, treatment with therapy (MDT) are indicated for: debridement of the maggots. treated with maggot debridement dressings, non-healing necrotic skin and soft-tissue wounds $Patients with fever or changes in mental status because the dressings may interfere with the Medical Maggots. such as pressure ulcers, neuropathic foot ulcers, should be evaluated for spread of infection close and frequent observation that these chronic leg ulcers, or non-healing traumatic or (i.e., bacteremia, cellulitis) or elevated serum patients require, and because MDT may delay post-operative wounds. ammonia levels. Maggot dressings may need definitive treatment (i.e., surgery). to be removed immediately to facilitate $Maggot therapy is not indicated as the primary wound inspection. treatment for infected bone or tendons. These Dosage & Administration - if contaminated or if not viable upon arrival. No The recommended dose of Medical Maggots After the Medical Maggots have been applied, Overdosage - warranty is made or implied regarding their is 5-8/cm2 of wound surface; applied topically. If cover them with a little loose gauze, and cage Large maggot burdens in blow fly infested sheep long-term viability, therapeutic efficacy or safety the eggs have not hatched by the time they them within the wound using a perforated (> 60,000 maggots per animal) are associated for any specific patient. arrive, hatching will be hastened by warming the material such as Creature Comforts (made with serious complications (“blow fly strike” vial in an incubator (i.e., 37oC). If the eggs are from Dacron chiffon, 70 weaves per inch), including elevated serum ammonia levels Complications and adverse events - brown and no maggots are seen, the maggots Tegapore (3M), or nylon stockings. A multi- (presumably due to the large protein breakdown Report problems or complications immediately may have died within their shells during layered maggot dressing is shown in Figure 1; in the wound), and encephalopathy. Neither to the manufacturer (949-679-3000), shipping. Do not use. Call supplier immediately detailed description of dressing designs can be elevated serum ammonia levels nor hepatic supplier, or FDA. Incident report forms can be for refund or replacement instructions found in Plast Reconstr Surg 1997; 100: 451-6; encephalopathy have been reported in humans; found on the internet at: immediately. and Arch Dermatol 1996;132: 254-256 but they should be sought in patients who www.MonarchLabs.com/forms/ae-report.pdf develop fevers or altered mental states while Air must be able to enter through the dressings receiving maggot therapy. Furthermore, patients (so that the maggots do not suffocate) and the should not be treated with more than 3,000 Inquiries and Orders - liquefied necrotic tissue must be able to drain larvae at a time. Medical Maggots are produced and

out through the dressings. Place a light gauze top distributed according to specifications by dressing over the cage layer, to absorb the It has been suggested that too many maggots within a rigid dressing --- especially in an Ronald Sherman, by: drainage; and change this gauze every 4 - 8 hours. Leave the maggot dressings on for insensate wound --- could cause increased approximately 48 hours. Beware: maggots may pressure on the wound as the maggots grow. This could lead to further ischemia and MONARCH LABS try to escape from the wound. What’s “new” in wound treatment of the wound, leading to further debridement and Dressing removal. To remove the maggot cage growth of the maggots, leading to more pressure 17875 Sky Park Circle, Ste K dressings with minimal effort, loosen the maggot still. Although never reported, this explanation Irvine, CA 92614 must be considered in patients whose wounds cage dressing from the patient’s skin, and then Phone: (949) 679-3000 peal back the dressing with one hand while are expanding during treatment. Fax: (949) 679-3001 wiping up the maggots with a wet 4" x 4" gauze e-mail: [email protected] pad held in the other hand, sandwiching the How supplied - maggots between the two hands. Discard the Each vial contains approximately 1,000 P. www.MonarchLabs.com maggots as you do your other potentially sericata eggs, from which at least 250 Medical infectious dressing waste (ie, discard in "red Maggots should have hatched. Each vial also contains 2" x 2" gauze and sterile food. Many of Dressing application. To apply Medical bag" securely sealed to prevent escape. Double- the larvae will be in the gauze pad and difficult Maggots to a wound, gather the maggots on a bag the sealed bag within another sealed bag for added security). to see; others will be crawling along the sides of sterile, moist (ie, normal saline or water) gauze the vial. Date of preparation is recorded on the pad, and place on the wound surface. Often the Duration of maggot therapy. The total number vial as the “batch number” (YY/MM/DD). Every maggots will crawl up the sides of the vial when batch is tested for sterility. the vial is warmed to > 30oC (the heat increases of cycles will depend upon the size and character of the wound, clinical response, and goals of their metabolism and activity). They can then be Restrictions and Disclaimers - wiped from the sides of the vial with a moist therapy. Most ulcers are completely debrided within 1 to 6 cycles. Medical Maggots are provided for the sole sterile gauze. Alternatively, Medical Maggots purpose of patient care, as prescribed by the in the gauze pad supplied with the vial can be Disposal - ordering physician. The recipient is not applied directly to the wound, or the maggots After use, handle and discard Medical Maggots authorized nor licensed to rear, breed, re-sell, or may be rinsed out of the vial with sterile water and the maggot dressings as you do your other redistribute these larvae or their progeny without or saline and poured over a sterile gauze pad. infectious dressing waste (ie, discard in "red specific permission. Unused larvae must be Then apply the gauze directly onto the wound. bags" destined for autoclaving or incineration). destroyed and not allowed to mature. Note: there may be more maggots in the gauze To prevent escape, seal the bag securely, and than you can see. It is strongly recommended seal that bag within a second, sealed waste bag Practitioners outside the Continental United that the materials for the cage be assembled and [see also Dosage and Administration - Dressing States require valid import permits by their local the foundation be affixed to the patient prior to removal]. Unused larvae must be destroyed in a Departments of Agriculture before ordering or applying Medical Maggots, since the maggots similar fashion; they may not be allowed to accepting Medical Maggots. Practitioners in will move quickly once they are applied, and mature. The recipient is not authorized nor Europe should contact one of the European they may rapidly emigrate out of the wound. licensed to breed, re-sell, or redistribute Medical commercial suppliers, listed on our internet site. Refrigeration for 30 minutes will slow the Maggots without specific permission [see activity of Medical Maggots. Restrictions and Disclaimers]. Medical Maggots will be replaced or refunded