Technical Bulletin June 2003 TB1-03

Agricultural, cosmetic, veterinary and medical use of emu-based products has soared in the last decade. This Technical Bulletin addresses the use of TopicAid®, a new, patented emu-oil based topical spray for use in veterinary applications of wound healing. University laboratory testing has proven TopicAid® to have anti-microbial, bactericidal, antiseptic, and antifungal properties. TopicAid®, patented in 2002, is being used extensively in a variety of professional and veterinary settings with superior results in promoting wound healing and reducing scarring.

Healing of a skin wound in mammals is a mixture of regeneration (creation of the same cell types as originally damaged) and replacement (substitution of a new cell type for an old one). Scarring is the result of replacement, so the more regeneration that can occur, the less scarring will be left behind after wound healing.

Wound healing typically follows a fairly typical time course in mammals, though the presence of pathogens can lengthen the recovery time (Hackam and Ford, 2003). Generally, within a few minutes of the initial damage to the tissue, which almost always results in trauma to blood vessels, a plug of platelets and other blood products (blood clot) forms at the site of tissue damage and stops further loss of blood.

Within hours of receiving the wound, debris-eating white blood cells called neutrophils have invaded the area of damage, signaling the start of the inflammation response. Inflammation is a series of events that includes increased blood flow, increased blood vessel permeability, activation of pain receptors and intense consumption of cell debris and bacteria by neutrophils and other white blood cells. Neutrophils ingest introduced bacteria and dead and dying cells in the wound, and are themselves killed in the process. The accumulating mixture of dead neutrophils and fluid forms pus. Typically within a few days, the surface of the clot has dried to form a scab. Now macrophages (another type of specialized white blood cell) infiltrate the wound, where they ingest dead neutrophils and other cellular debris.

Within a week after the wound occurred, tough, fibrous cells called fibroblasts move in from surrounding connective tissue and start to multiply at the wound site. The fibroblasts begin to secrete collagen fibers. At the same time, new epidermis begins to regenerate. New endothelial cells from neighboring undamaged tissue begin to form new capillaries that grow into the repairing wound site to supply blood to the newly forming epidermis.

Within a few weeks, the rapidly dividing epidermis completely lines the original wound site. The fibroblasts generate new connective tissue (scar tissues), which replaces the epidermis destroyed by the wound. Scar tissue persists after the healing of particularly severe wounds. The rapidity and effectiveness of skin wound repair depends on several factors (Burns et al., 2003). Proper nutrition is essential (Russell 2001). Vitamins C, D, E, and K all play important roles at some stage in the tissue repair process (Casey, 2003). Agents that increase cell division, such as the emu oil found in TopicAid®, will also hasten wound healing (Snowden et al., 1997; Politis and Dmytrowich, 1998; Lopez et al., 1999).

A growing appreciation of the superior nutritional characteristics of emu meat (Fukushima et al., 1999; Daniel et al., 2000; Beckerbauker, 2001) has led to a considerable increase in the number of emus raised in both the US and abroad (especially Australia, where the emu is indigenous). Associated with the rising popularity of emu meat as a food product is an increase in the production of commercial and fully refined oil rendered from the copious amounts of subcutaneous fat in the processed bird.

Emu oil based cosmetic and health products, which have burgeoned in recent years, derive their popularity from the numerous positive properties of emu oil. These include scientifically supported descriptions of cosmetic applications as a skin moisturizer (Zemtsov, 1996) and skin restorer. (Snowden et al., 1997; Politis and Dmytrowich, 1998; Lopez et al., 1999).
The Emu Oil Institute additionally provides anecdotal reports on their web site (www.emu-oil.com) of emu oil's benefits in symptomatic relief and treatment of a variety of skin ailments, including eczema, psoriasis, rosacea, ichthyosis, alopecia areata, as well as other skin and superficial diseases that can be treated with anti-inflammatory substances.

Lucid Med Tec II, Ltd. a Texas-based veterinary and medical pharmaceutical company introduced TopicAid® in late 2002. TopicAid® is a patented, topically applied, spray containing emu oil. TopicAid® is effective in the symptomatic relief and treatment of chronic cutaneous ulcers, burns, mechanical wounds and abrasions in horses, dogs and cats. This patented product is also suitable for application to fresh wounds and surgical incisions; it can also be used to accelerate already healing wounds.

The oleic-rich emu oil within TopicAid® enables epidermal tissue to regenerate, restore, and rebuild in the wound itself and in underlying dermal and subcutaneous tissue, thereby fortifying non-necrotic epidermal and dermal cells, and revitalizing potential necrotic cells. (Snowden et al., 1997; Politis and Dmytrowich, 1998; Lopez et al., 1999). A major clinical benefit of TopicAid® is reduced wound sepsis rates due to the formulation?s proven antibacterial properties (D. Kunz, unpub.).TopicAid® also provides improved rates of wound closure (including surgical incisions) and reduced healing times. The formula reduces wound debridement and increases epidermal cell proliferation, while maintaining and feeding skin cells. The development of proud flesh, a common ailment in wound treatment in horses, is retarded or even prevented. Reduced scarring is evident, leading to improved function (e.g. range of motion, contour and profile of healed skin, normalization of skin pigmentation, markings, hair coat).

TopicAid® is a proprietary health product made from fully refined emu oil as a transdermal facilitator. Also containing benzyl alcohol, C12-15 alkyl benzoate, allantoin, methylparaben and propylparaben, TopicAid® is formulated into a convenient topical spray.
The composition of purified, fully refined emu oil is well characterized, and comprises approximately 70% unsaturated fatty acids. The primary fatty acid by % composition is oleic acid (49%), a known penetration enhancer (PE) for transportation of compounds through dermal pores in human skin, and thus, in delivering the active ingredients into the highly perfused subcutaneous layers (Touitou et al., 2002; Jiang, and Zhou, 2003). The lipid composition of emu oil is presented in the following table:

Emu oil closely reflects the lipid composition of mammal skin (including that of humans), which likely contributes to its rapid and effective transdermal migration. Emu oil additionally contains a Calculated Iodine Value of 69-72.8 mEq/100g oil.

The considerable similarity between the fatty acid composition of emu oil and human skin, combined with the large concentration of oleic acid, contributes to the skin penetrating powers of emu-oil based products, including TopicAid®.

Lucid Med Tec II, Ltd. has developed a patented line of veterinary (equine, dog and cat) and human wound healing products. A major R&D goal is to expand and improve upon the relatively few numbers of professionally conducted biomedical experiments that currently support the voluminous anecdotes and testimonials accompanying non-patented emu- oil based health products.

Lucid Med Tec II, Ltd. recently sponsored an investigation at a microbiology laboratory at the University of North Texas (Denton, Texas). This investigation has conclusively proven that TopicAid® has statistically significant, and potent, anti-bacterial properties. It is especially effective against Staphylococcus aureus, Enterococcus faecalis and Pseudomonas aeruginosa (three common pathogens in horse and small mammal wounds Jacks et al., 2003).
A second investigation funded by Lucid Med Tec II, Ltd. and currently underway involves a clinical trial at a respected Midwestern School of Veterinary Medicine, to determine the effectiveness and mechanism of action of TopicAid® in small mammals.

TopicAid® is designed to be applied as a drenching spray directly onto the affected area twice daily or as needed. More frequent applications may be indicated when a partial thickness wound is large, or for a surgical incision.

The shelf life of TopicAid® has been determined to be at least 2 years at 60-86 degrees Fahrenheit (15-30 degrees Celsius). Products may be refrigerated, but should be warmed to room temperature for application.

No contraindications have emerged in two years of field trialsof TopicAid®. Lucid Med Tec II does not know of any product failure such as adverse reactions, non-performance, or environmental hazards.

TREATMENT OF PROUD FLESH. Proud flesh, an unsightly accumulation of granulation tissue resulting from poor wound healing, is commonly removed surgically (which produces additional scarring) or through various caustic solution treatments (which can eat into the skin and surrounding area, also leaving scarring). Typically in many cases, the hair that re-grows over the wound losses its pigment and the hair re-growth is a white color.

May 20, 2002. - Magnum's Promise, owned by Kimberly Tillman (Flower Mound, Texas), was a three-month-old Arabian show horse when it was wounded after becoming entangled in a stall. The wound quickly formed proud flesh, significantly reducing Magnums Promise?s show value.

This photo (May 20, 2002) was taken the first day the protective covering was removed by a veterinarian who had been treating the wound for two weeks with a traditional topical solution and covering. The wound was not healing and proud flesh (arrows) had formed over the wound, which was still bleeding. The same day this photo was taken, treatment was started with TopicAid® Spray for Equines. TopicAid® Spray for Equines was applied 2 times per day without special cleansing or preparation, and the wound left open rather than bandaged. The colt did not flinch or show any discomfort, because TopicAid® Spray did not require application by rubbing and/or bandaging, as do typical treatments for proud flesh.

June 10, 2002. Twenty days after twice daily spraying of TopicAid® Spray for Equines on the afflicted area, the wound on Magnum's Promise?s leg had closed, and the proud flesh dissipated.

There was no sign of tissue damage or scarring, which can result in pigment loss to hair on the site of the wound and surrounding area.

June 27, 2002. After 37 days of twice daily treatment with the TopicAid® Spray for Equines, without bandaging, the now 4-month-old colt had no semblance of a wound, scarring, proud flesh or loss of pigment to the hair in the original area of the horse?s wound.

A total of 6 ounces of the TopicAid® Spray for Equines formula was used over the 37-day period. The horse appeared to have had no adverse reactions to the formula. In Magnum?s Promise?s case, TopicAid® Spray for Equines proved to be a fast, efficient and cost-effective method of treating its wounds and preventing proud flesh formation.

And what of Magnum?s Promise? Now a yearling, the horse will be promoted as Horse of the Year in its class.

TREATMENT OF SUNBURN

August 14, 2002. Rugby, a 14-year-old Pinto breed and a polo horse owned by Terri Freeman of Flower Mound, Texas was at a boarding facility when it was left out in the hot Texas sun too long and was badly sunburned over 75% of his body. Rugby?s hair fell off, his skin blistered and dried out, and Rugby could hardly move, walk or lay down. In some spots he had severe blisters on his skin.

The horse was brought into a barn and bathed with cool water. Once the horse had dried, TopicAid® Spray for Equines was simply sprayed on the affected areas (75% of his body) twice a day and allowed to penetrate, without covering or bandaging. This regimen was maintained for 3 weeks total. During the application of the product, the horse appeared to be comforted by the application of TopicAid® Spray for Equines. The owner reported that its analgesic/anesthetic action immediately helped. After the first week of regular treatments, Rugby was able to lie down in the stall without any discomfort. Also after the first week, the redness of the sunburn dissipated, as well the sores began to heal and the hair started to grow back. TopicAid? treatment was continued regularly for the next two weeks at two times per day.

September 4, 2002. After 21 days, Rugby was back to normal, all blisters were gone, and no semblance of sunburn was evident. Healthy tissue was covered by growing hair with no scarring. A total of 8 ounces of TopicAid® Spray for Equines was used during the 21-day period, with no adverse affects. The owner reported that the quantity of product used is minimal as compared to other products currently available.

TREATMENT OF AN UNIDENTIFIED, RHEUMATIC FEVER-LIKE ILLNESS

November 21, 2002. Myra was a 12-year-old pleasure horse that fell victim to a disease that its veterinarian could not identify, but viewed as similar to Strangles. The horse had lost 400 pounds, its ribs were quite evident, and it generally appeared unhealthy. The wounds in the photo below covered approximately 60% of its body. Its skin would appear to rot and fall off the flesh, exposing underlying flesh of unhealthy tissue color and composition. The resulting large pockets were described to be as ?as deep as a finger?.

Veterenarian recommended that the horse be destroyed. Myra?s owner contacted Lucid Med Tec II and received TopicAid® Spray for Equines. The horse was washed with water prior to each application of the TopicAid® Spray for Equines, in the form of a simple spraying of the affected areas twice a day for 3 weeks. A total of 8 ounces of TopicAid? Spray for Equines was used over a 21-day treatment period.

December 14, 2002. In an amazing turnaround for Myra, just 24 days after starting treatment with TopicAid® Spray for Equines, the afflicted flesh had returned to a healthy red color and the skin appeared to be strengthening and re-attaching itself to the underlying flesh. The wound was rapidly closing, with no sign of proud flesh formation, scarring or loss of pigment to the hair. Myra started to eat soon after treatment began, and had re-gained 200 pounds at the time of the photo below.

The owner subsequently reported the horse?s complete recovery. Myra?s owner also reports other success with minor scrapes, puncture wounds, bites and incision marks, as well as bacterial and fungal growths.

Emu oil, a food byproduct, is an all-natural substance obtained from the fat of the emu, a ratite bird related to the ostrich, rea and cassowary. Many emu oil products currently used in medical and veterinary medicine have not been refined, but instead are simply rendered. In the rendering process, the oil is only filtered, leaving contaminants within the final product. TopicAid®, on the other hand, uses high quality, fully refined emu oil produced through an expensive, multi-step process of refinement and deodorization. This yields a pure, creamy white and odor-free oil. Additionally, the emu oil in TopicAid® has been formulated for use as a preparation for treatment of open, potentially septic wounds.

TopicAid® is a cost-effective, easily applied topical spray that promotes healing of surgical incisions, mechanical wounds and abrasions, and burns. It is indicated especially where both animal comfort and ultimate appearance of the skin/coat is important to the value of the animal. Wound healing is accelerated, and the ultimate appearance of the wound site is such that scar tissue formation is greatly reduced, an important consideration for valuable show animals.

Beckerbauer, L.M., Thiel-Cooper, R., Ahn, D.U., Sell, J.L., Parrish, F.C. Jr., Beitz, D.C. 2001. Influence of two dietary fats on the composition of emu oil and meat. Poultry Science Feb;80(2):187-94.

Burns, J.L., Mancoll, J.S., Phillips, L.G. 2003. Impairments to wound healing. Clinical Plastic Surgery. 30(1):47-56.

Casey, G. 2003. Nutritional support in wound healing. Nursing Standards 17(23):55-8.

Daniel, D.R., Thompson, L.D., Hoover, L.C. 2000. Nutrition composition of emu compares favorably with that of other lean meats. Journal American Diet. Association. Jul;100(7):836-8.

Fukushima, M., Ohashi, T., Sekikawa, M., Nakano, M. 1999. Comparative hypocholesterolemic effects of five animal oils in cholesterol-fed rats. Bioscience, Biotechnoogicy and Biochemistry. Jan;63(1):202-5.

Hackam, D.J., Ford, H.R. 2002. Cellular, biochemical, and clinical aspects of wound healing. Surgical Infection (Larchmt). 3 Suppl 1:S23-35.

Jacks, S.S., Giguere,S., Nguyen, A. 2003. In vitro susceptibilities of Rhodococcus equi and other common equine pathogens to azithromycin, arithromycin, and 20 other antimicrobials. Antimicrob Agents Chemother. 47(5):1742-5.

Jiang, S.J., Zhou, X.J. 2003. Examination of the mechanism of oleic Acid-induced percutaneous penetration enhancement: an ultra structural study. 2003. Biological and Pharmacological Bulletin. 26(1):66-8.

Lopez, A., Sims, D.E., Ablett, R.F., Skinner, R.E., Leger, L.W., Lariviere, C.M., Jamieson, L.A., Martinez-Burnes, J., Zawadzka, G.G. 1999. Effect of emu oil on auricular inflammation induced with croton oil in mice.
American Journal of Veterinary Research Dec;60(12):1558-61.

Politis, M.J., Dmytrowich, A. 1998. Promotion of second intention wound healing by emu oil lotion: comparative results with furasin, polysporin, and cortisone. Plastic Reconstructive Surgery Dec;102(7):2404-7.

Russell, L. 2001. The importance of patients' nutritional status in wound healing.
British Journal of Nursing. 10(6 Suppl):S42, S44-9.

Snowden, J.M., Whitehouse, M.W. 1997. Anti-inflammatory activity of emu oils in rats. Inflammopharmacology ;5:127-132.

Touitou, E., Godin, B., Karl, Y., Bujanover, S., Becker, Y. 2002. Oleic acid, a skin penetration enhancer, affects Langerhans cells and corneocytes. Journal of Controlled Release. 23;80(1-3):1-7.

Zemtsov, A., Gaddis, M., Montalvo-Lugo, V.M., Zemstov, A. 1996. Moisturizing and cosmetic properties of emu oil: a pilot double blind study. Australasian Journal of Dermatology Aug;37(3):159-61.

TopicAid® is a registered trademark of Lucid Med Tec II, Ltd.

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