Topical skin adhesive excels in cosmetics trial
FDA approves product to replace sutures, staples
A study appearing in Plastic and Reconstructive Surgery highlights findings from a one-year period that show patients treated with Dermabond, a topical skin adhesive, experience superior cosmetic outcomes compared to patients treated with sutures.
Dermabond adhesive, according to its manufacturer, is designed to replace sutures, staples, and adhesive strips for closing certain topical incisions and lacerations. It is the first such product to be approved by the Food and Drug Administration for the U.S. market.
Dermabond is licensed by Closure Medical, which gave marketing and distribution rights to Ethicon Inc.
One hundred eleven patients participated in the trial, which was conducted in a facial plastic and reconstructive surgery setting. Patients were assigned to two groups: those with wounds requiring subcutaneous sutures or wounds without subcutaneous sutures. The two groups were then randomized to receive treatment with either Dermabond or sutures.
Surgeons rate one-year post-op photos
At one year after surgery, photos of the healed wounds were given to two independent facial plastic surgeons who were unfamiliar with the study design. They were asked to rate the appearance of the healed incisions.
Each surgeon was asked to rate the cosmetic result using a visual analog scale, which is more specific than the scale used at 90 days during a clinical study submitted to the Food and Drug Administration. At one year post-treatment, the two plastic surgeons, after evaluating the photos, concluded that the group treated with the adhesive had better cosmetic outcomes than the group treated with sutures. In addition, there were no instances of wound dehiscence, hematoma, or infection among the group treated with the adhesive.
"The advantages of tissue adhesive in skin closure are significant to both patients and physicians, providing faster, relatively painless closure as compared to sutures," says lead author Dean M. Toriumi, MD, associate professor in the Division of Facial Plastic and Reconstructive Surgery at the University of Illinois in Chicago. "Our study finds that in certain applications and with proper wound management, tissue adhesive also provides a better cosmetic result than sutures. This is particularly important for use in surgical procedures on the head or face, where scarring is an important consideration."
Dermabond is intended for topical application to close easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. The manufacturer warns that the product should be used in conjunction with, but not in place of, subcuticular sutures when they are required.
The company also stresses that the adhesive must not get into the wound or be used beneath the skin. It should not be used across areas of skin tension, such as knuckles, elbows or knees, unless the joint will be immobilized during the wound healing process. Dermabond adhesive should not be used on patients with a known hypersensitivity to cyanoacrylate or formaldehyde, or on any wounds with visual evidence of active infection, gangrenous wounds, or wounds from decubitus ulcers. It also should not be used on mucosal surfaces or internally.
Ethicon estimates that skin closure products could be used in approximately 90 million procedures, and that annual suture and staple sales total $2.6 billion.