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Sunday, August 5, 2012

Spray-on Skin May Promote Wound Healing

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Experts Predict Role for Spray-on Skin in Slow-Healing Wounds

By Denise Mann
WebMD Health News

Reviewed by Louise Chang, MD

Aug. 2, 2012 -- An experimental spray-on skin product may help people with chronic leg wounds heal faster and more effectively than available treatments, a new study suggests.

The spray-on skin is made up of skin cells and suspended in a mixture of different types of proteins. The participants in this study all had venous leg ulcers, which are shallow wounds that occur in people who have a circulation problem in their veins. These wounds tend to develop on the inside of the lower leg. Most at risk for venous ulcers are inactive and obese people, as well as people with varicose veins.

People in the study who used the new treatment experienced a greater reduction in wound size than those who didn't use it.

The findings appear in the Lancet.

Healthpoint Biotherapeutics of Fort Worth, Texas, is developing the new product and sponsored the study.

As it stands, most venous leg ulcers are treated with compression bandages. Some doctors also use skin grafts in which skin is taken from another area of the body and used to resurface the wound. Skin grafts involve surgery, and people can develop a wound at the skin donation site, too.

"If you don't get these to heal, they become chronic, and the older the wounds are, the harder they become to heal with anything," says researcher Herbert B. Slade, MD. He is a pediatrician at the University of North Texas Health Science Center in Fort Worth and is also the chief medical officer at Healthpoint Biotherapeutics. "Compression bandages work for 30% to 70% of people, but are not 100% effective."

That is where the spray-on treatment may come in.

In the 12-week study of 205 people, those who received the spray-on treatment and compression bandaging had a greater reduction in wound size than those who used compression bandaging without the test treatment.

Researchers tested two strengths of the new therapy, along with compression bandages. The biggest improvements were seen in the lower-strength dose given every two weeks; there was a 16% greater reduction on average of the wound area, compared to a group that was given a spray that didn't contain the new therapy, after 12 weeks.

Side effects were similar in the different groups. The spray-on treatment sped wound closure by an average of 21 days compared to the comparison group.

Slade and colleagues are now assessing its safety and conducting studies to determine exactly how it works. "The FDA wants us to better define what it is that is happening when the cells get on the surface of the wound," he says. "We know it works, we just need to know more about how."

According to Slade, the sprayed-on cells help the tissue learn how to regenerate itself. If the findings are confirmed by follow-up studies, "it's going to be an off-the-shelf product." No information is available about cost at this time.

The need for new products to treat these wounds is tremendous, Matthias Augustin, MD, says in an email. "A significant number of patients fail to respond to any therapy."

Augustin, the director of the Institute for Health Services Research in Dermatology and Nursing at the University Clinics of Hamburg in Hamburg, Germany, wrote an editorial accompanying the new study.

"New treatments with improved healing and healing rates are needed to reduce the burden of ulcers for patients, [and] while more research is needed I believe that this product could ultimately make a significant difference for these patients."

John Lantis, MD, is one of the investigators on the study. "This could be used in any place that artificial skin is needed, such as diabetic foot ulcers," says Lantis, who is the chief of the vascular surgery division at St. Luke's-Roosevelt Hospital in New York City.

It will not be a stand-alone treatment. "If you have a diabetic foot ulcer, you will still have to wear special diabetic shoes," he says. "It's not like you can just spray it on and go about your business. It will always be used in conjunction with current standard of care."

It seems to perform better than any other artificial skin products out there or in the pipeline, Lantis says.

Maja Zaric, MD, says there may well be a role for this product. She is an interventional cardiologist at Lenox Hill Hospital in New York City. "The spray can be applied in various doses and it is very user-friendly, unlike a skin graft."

Still, not every person with a venous leg ulcer would benefit from the new spray-on skin. "Those who would benefit the most have extremely large ulcers and decreased blood flow," she says. Before treating these wounds, Zaric always does a vein-mapping study to see which veins are causing the problem.

Neil Sadick, MD, is a New York City dermatologist and clinical professor of dermatology at Weill Cornell Medical College. "This treatment provides a cocktail of cells and growth factors," he says. "These ingredients can stimulate new collagen, which would improve wound healing and also help recover the skin." Collagen is the main structural protein in skin.

"It could well be helpful in wound healing and it could be helpful in any area where we need to replace the skin surface," Sadick says.

SOURCES: Herbert B. Slade, MD, pediatrician, University of North Texas Health Science Center, Fort Worth, Texas; chief medical officer, Healthpoint Biotherapeutics. Neil Sadick, MD, clinical professor of dermatology, Weill Cornell Medical College, New York City. Maja Zaric, MD, interventional cardiologist at Lenox Hill Hospital, New York City. John Lantis, MD, chief, Vascular Surgery Division, St. Luke's-Roosevelt Hospital in New York City. Kirsner, R.S. Lancet, 2012, study received ahead of print.

©2012 WebMD, LLC. All Rights Reserved.



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Options Increasing for Coping With Kids' Food Allergies

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By Serena Gordon
HealthDay Reporter

FRIDAY, Aug. 3 (HealthDay News) -- Kids with a serious food allergy generally have to steer clear of the offending food, but methods now under development could change that common scenario.

More than 3 million American youths -- about one of every 25 -- have a food allergy of some sort, usually to milk, eggs or peanuts, according to U.S. government statistics. For them, "avoidance has been the mainstay of treatment for a long time," said Dr. William Silvers, an allergist in private practice in Vail, Colo., and a spokesman for the American College of Allergy, Asthma and Immunology.

"Now what we're seeing is an increased interest in oral immunotherapy," Silvers said. "This means giving small and slowly increased doses orally of foods that children are allergic to, and building up the amount ingested over time to desensitize the child to the food so they can tolerate it."

That doesn't come string-free, though. Dr. Carla Davis, an allergist at Texas Children's Hospital in Houston, noted that once children have been desensitized to a certain food, they have to continue eating it regularly or they'll become allergic to the food again.

"There isn't a maintenance of tolerance if you avoid the foods," she explained.

Along with desensitization, another potential new treatment for food allergies is a drug called omalizumab (Xolair). Silvers said that it works by blocking the activity of the allergy-causing substance known as immunoglobulin E (IgE) so that an allergic reaction never starts.

However, the food allergy would come back if a person were to stop using the drug, which is currently available only in an injectable form and has not been approved by the U.S. Food and Drug Administration for use in children younger than 12.

Some researchers, though, think that a combination of the two treatments might be better than either alone. Early reports from a very small study found that nine of 11 children who were given Xolair and then desensitized to milk were able to consume up to 12 ounces of dairy a day without a reaction.

Davis said that researchers also are testing herbal formulations and that one particular combination of nine herbs was able to prevent a serious allergic reaction, known as anaphylaxis, in mice. "It's another one of the treatments that may be up-and-coming," she said, though there's no evidence in humans yet.

What has been proven true, though, is that many kids simply outgrow their food allergies, even some of the most deadly ones. Davis said that as many as one in five youngsters may outgrow an allergy to peanuts but that allergies to eggs, milk, soy and wheat are most often outgrown. In general, peanuts, tree nuts and seafood allergies tend to stay with children as they grow, she said.

To know whether a child has outgrown a food allergy requires repeated skin and blood tests, Silvers said. "If IgE levels in the blood decrease over time, or if skin testing comes back negative or a very small reaction, a child or adult can be given a food challenge to see if they'll react," he said.

To be safe, though, the testing "must be done under a physician's supervision," Davis said, because a serious reaction could occur if the youngster has not outgrown the allergy.

For kids with lingering food allergies, Silvers recommended that the child or parent always carry the antihistamine Benadryl and an epinephrine injection pen. If it's suspected that the child accidentally ingested an allergy-inducing food, the youngster should take the antihistamine right away. If the allergic reaction worsens, administer the epinephrine and get to an emergency room as quickly as possible.

It's important to go to the hospital after a serious allergic reaction, Davis said, because there can be a second wave to the reaction about four to six hours later.

Many children have their own epinephrine pens at their school nurse's office. In Chicago, the public school system recently decided to take the next step and keep a supply of epinephrine pens in every school, and train school personnel in their use, so that they're prepared for any serious allergic reactions.

"This is a good idea because about one in five children have their first serious reaction in school," Davis said.

For those living with food allergies, Davis said, it's important to find a balance between being vigilant and being overanxious. Parents should be "prepared for a reaction, but shouldn't expect one all the time," she said. "Some parents become extremely anxious about the contact their child may have with food. Health vigilance is important, but so is quality of life."

MedicalNewsCopyright © 2012 HealthDay. All rights reserved. SOURCES: Carla Davis, M.D., assistant professor, pediatrics, section of allergy and immunology, department of pediatrics, Texas Children's Hospital, Houston; William Silvers, M.D., allergist, Allergy Asthma Colorado, Vail, Colo.



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