Skin Burn Treatments : Cellular Wound Dressings

by Food and Drug Administration (FDA)

(Page 4 of 4)

Humanitarian Use of Cellular Wound Dressing

Children with a rare inherited, incurable disease called epidermolysis bullosa (EB) have a painful existence. In this disease, a genetic defect causes the skin to lack certain proteins that protect it from damage. Blisters and wounds develop easily on the fragile skin, particularly on fingers and toes. Life-threatening infections may set in when the wounds don't heal, and for those that do, they leave behind scar tissue. The scarring can make the fingers grow together into a gnarled fist that looks like a mitten, rendering it useless.

In 2001, the FDA approved OrCel, a cellular wound dressing, to help surgeons reconstruct the hands of people with EB. Once the fingers are surgically separated, OrCel is used to rebuild the "mitten hand."

OrCel is used on the fingers, thumb, and the palm of the hand, says Mark Eisenberg, M.D., developer of OrCel and co-founder of Ortec International, New York, the company that markets the product. It's also used on the wounds left after taking healthy skin from other parts of the body (donor sites) to help repair the hand. Depending on the severity of the disease, surgeons often must repeat the hand reconstruction, says Eisenberg. But OrCel significantly reduces the need for donor sites in these surgeries. Eisenberg originally developed the product and used it to treat his son, who had EB.

The FDA approved OrCel to help treat EB under a special program for humanitarian use devices (HUDs). A HUD is intended to benefit people with a disease or condition that affects fewer than 4,000 individuals in the United States each year. The regulations regarding HUDs exempt the product from extensive clinical studies while still requiring data to show evidence of safety. These reduced requirements help product developers offset their research and development costs for products that treat a relatively small population.

Becoming a Skin Donor

On April 17, 2001, Health and Human Services Secretary Tommy G. Thompson launched a national organ donor initiative to encourage Americans to "Donate the Gift of Life." "Fifteen Americans die each day while waiting for an organ to become available," says Thompson. "More than 75,000 men, women, and children now wait for a transplant ... Every 16 minutes, another person joins the waiting list."

Many people don't realize that skin is an organ, but in fact it's the body's largest organ. And like other organ donations, skin donations are critically needed, says Phil Walters, director of the skin bank at Boston Shriners Hospital. Walters says the two most frequently asked questions he fields about skin donation are: is skin taken from a living donor, and can tissue surgically removed from a patient by procedures such as those performed to reduce obesity be donated? "The answer to both questions is no," says Walters. "Skin is procured from a deceased organ donor, just like any other donated organ."

No charge is made to the donor's family for donating organs. And it does not change the appearance of the donor's body or cause a delay in funeral arrangements.

Cellular Wound Dressings and Terrorism

The Pentagon, headquarters for the American military and one of the world's largest office buildings, was one target of the terrorist attacks of Sept.11, 2001. A few miles from the Pentagon, at the Washington Hospital Center, surgeons worked around the clock to treat people who were severely burned from the Pentagon explosion.

Surgeons moved quickly to prevent infection by first removing burned tissue on each person, and then covering the open wounds using cadaver skin, pigskin, and two biosynthetic wound dressings approved by the FDA: Integra and TransCyte. All of the wound coverings were used temporarily to thwart bacterial infection until the burned person's body could heal itself or the person's own skin could be grafted. "They reduce the load of burned tissue, which has a poisonous effect to the body," says Marion Jordan, M.D., director of the Washington Hospital Center's burn center.

Jordan prefers to use skin donated from another person (known as cadaver skin, or human allograft). "Human allograft is still the best alternative to a person's own skin, but I rely on all of the products out there," says Jordan. "I believe each has a place [in the treatment of burns]."

The development of cellular wound dressings to treat burns and wounds is still in its infancy. "This is a small field, but it can have unusual, unexpected, and positive consequences," says Phillip Noguchi, M.D., director of the FDA's division of cellular and gene therapy. "We're committed to moving this area forward. Just as we move forward on many fronts, including fighting anthrax and smallpox, these other efforts will also have an impact on our ultimate response to terrorism."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.