In the United States, chronic wounds and skin ulcers affect approximately 10 million people. The annual cost of treating chronic wounds and skin ulcers in the U.S. is estimated, conservatively, in the multi-billions of dollars. The incidence of chronic wounds and skin ulcers are on the rise due to an aging population, obesity, and diabetes.
Good News for the Treatment of Chronic Wounds and Skin Ulcers:
There is a new FDA approved treatment for chronic wounds and skin ulcers. It is purified human tissue derived from amniotic membranes. The brand name of the treatment is Epifix. It is loaded with growth factor proteins and cytokines that accelerate the healing process.
These growth factor proteins cause a patient’s own cells to move towards the wound site and help the ulcer site to heal by encouraging a patient’s own cells to regenerate and repair the damaged tissue or ulcer.
In fact, the treatment has over 200 different growth factors and other proteins that actually block enzymes that break tissue down that prevent the wound from healing. Amniotic proteins have been used to treat chronic wounds since the 1990s in over ½ million patients without any serious side effects.
What exactly is EpiFix?
EpiFix is tissue donated by healthy, consenting mothers undergoing a scheduled Caesarean section and delivering a live birth. Amniotic membrane is tissue that surrounds the baby and is typically discarded after birth. The recovery of the amniotic tissue does not harm the baby or the delivery procedure. The amniotic tissue donation does not have the ethical concerns associated with embryonic tissue donation.
The amniotic tissue is tested for infectious diseases, similar to the testing that is done for blood donation. The amniotic membranes undergo a special process that cleans, sterilizes and dries the membrane. The EpiFix production process is regulated by the Food and Drug Administration and accredited by the American Association of Tissue Banks.
The treatment is the application of a small piece of purified, dried and sterilized amniotic membrane that looks very much like a small piece of paper. The wound-site is cleaned; the paper-like treatment is placed at the bottom of the wound and covered with a dressing. This process is repeated weekly until the wound is healed. There is also a powder version of the product that can be mixed with saline and injected. Currently, insurance coverage for the procedure is not perfect, but it is very good and getting better monthly.
There are other uses as well. The treatment can be used on normal wounds such as standard surgical wounds and cosmetic surgical wounds to heal better, faster and with less scarring. The product can also be used to revise old painful scars to make them feel better and look better. This type of scar revision has been employed successfully to treat symptomatic and unsightly keloid scars.
Most wounds will heal in two to three weeks. If you or a loved one has a chronic wound or ulcer that is not healing in a timely manner, talk to your doctor to see if this medication is a reasonable treatment. Also, if you are considering surgery, ask your doctor if this is a consideration for better wound healing with less visible scars. Lastly, if you have painful scars, including keloid scars, talk to your doctor about using EpiFix to see if this treatment would be right for you.
Charles E. Crutchfield III, MD is a board certified dermatologist and Clinical Professor of Dermatology at the University of Minnesota Medical School. He also has a private practice in Eagan, MN. He received his M.D. and Master’s Degree in Molecular Biology and Genomics from the Mayo Clinic. He has been selected as one of the top 10 dermatologists in the United States by Black Enterprise magazine. Dr. Crutchfield was recognized by Minnesota Medicine as one of the 100 Most Influential Healthcare Leaders in Minnesota. He is the team dermatologist for the Minnesota Twins, Vikings, Timberwolves, Wild and Lynx. Dr. Crutchfield is an active member of both the American and National Medical Associations.