FDA Panel Approves Surgical Glue
Jan. 30, 1998
GAITHERSBURG, Md. (AP) _ Doctors may soon try a modified version of Super Glue as a painless way to close wounds instead of using heavy, scar-prone stitches or staples: Scientific advisers recommended Friday that the government approve the nation's first surgical glue.
DermaBond, made by Closure Medical Corp., takes far less time to apply than it takes to stitch up wounds, doesn't require a repeat visit to remove sutures and _ particularly important for children _ doesn't hurt, doctors told the FDA meeting.
``The addition of tissue adhesives should prove a rapid, painless alternative to sutures for one-third of patients'' treated in emergency rooms, said Dr. Judd Hollander of the University of Pennsylvania, who tested the glue.
``Cosmetically, it is better,'' added Dr. Dean Toriumi of the University of Illinois, Chicago, a plastic surgeon who showed photographs of nearly invisible scars on some of his test patients.
The FDA panel unanimously recommended that the government approve DermaBond, but advisers cautioned there's no proof DermaBond is better than sutures, just an alternative. The FDA is not bound by its advisers' decisions, but typically follows them.
Raleigh, N.C.-based Closure tested 814 patients over age 1. Between 75 percent and 84 percent of the glued patients had healed within 10 days, while 89 percent to 96 percent of patients who were stitched, stapled or treated with surgical adhesive tape had healed that fast.
That's not a statistically significant difference, nor was overall final healing and scarring different at three months, leading the FDA advisers to conclude the glue was probably as good as standard care.
There were slightly more infections in DermaBond patients, although not statistically significant. But the panel said doctors should be warned to thoroughly cleanse wounds _ even those that don't appear contaminated _ before sealing them with DermaBond.
Surgical glues are sold in other countries, and U.S. doctors often bring some back from trips abroad or mix some up in private labs to use on their own patients. But the FDA has never approved a surgical glue for sale in this country, and analysts predict DermaBond could quickly become a multimillion-dollar product.
DermaBond is a chemical similar to that used to make Super Glue, modified so that it doesn't harm delicate tissue. Doctors squeeze the liquid vial until the glue saturates an applicator tip and then roll the glue over the wound, much like rolling a tube of lip gloss.
Within 2 1/2 minutes, the glue sets, forming a see-through film that lasts five to 10 days. On a videotape, doctors squeezed and pulled skin to show the glue film is flexible and the cut didn't break open. The glue gradually wears off as new skin cells form beneath it.
DermaBond is only for skin-deep cuts, not very deep wounds, the FDA panel warned. Doctors could try it on cuts from accidents or for minimally invasive surgery.
It is not just to replace stitches on small wounds. For larger wounds, doctors would still use small sutures beneath the skin surface, and DermaBond then would hold the top layers of skin together for less scarring.
Toriumi, the plastic surgeon, uses that glue-suture combination in facial surgery. In his own study of 111 patients, those who got DermaBond had less swelling and inflammation and none of the suture scars that standard facial suturing can cause, he said.
Total treatment time _ including examining and cleansing a wound _ took half as long with DermaBond, Hollander said. Add that to no more need for a stitch-removal visit, and DermaBond should reduce medical costs, he said, although the company has not announced the glue's price.
``It was very desirable to patients,'' Toriumi said.