SDS patients will benefit from new tissue adhesives
SDS patients will benefit from new tissue adhesives
Increase hemostasis, expedite wound closure
Two new tissue adhesives, both approved this year by the Food and Drug Administration (FDA), are likely to find their way rapidly into same-day surgery because one product increases hemostasis and the other speeds wound closure.
Fibrin sealant, a tissue adhesive approved in May, increases surgical hemostasis, says Sandra Burks, RN, clinical coordinator of the Tissue Health Center at the University of Virginia Health Science Center in Charlottesville. The center, which develops tissue adhesives, is made up of representatives from various specialties.
"Fibrin sealant can be used to control diffuse slow bleeding over large surfaces and to join skin flaps or muscle flaps in procedures such as a mastectomy," Burks says.
The material is a "biologic glue" composed of naturally occurring proteins that causes blood to clot, thus forming a pliable seal and stopping the bleeding. Eventually, it is resorbed by the body without damaging tissues or leaving scars.
"That’s why it can be used internally," Burks explains. Although it has just been approved in the United States, it has been used on more than 3 million European patients, she says.
Use Fibrin to control bleeding
For outpatient programs that perform minimally invasive surgical procedures such as laparoscopies, fibrin sealant can be especially useful for patients who are at risk of bleeding.
"As you are removing the instrumentation, for example, you could control bleeding by putting fibrin sealant in places where you would not be able to get traditional sutures in," Burks says.
She explains that the tissue adhesive can be applied in several ways: First, surgeons may use a dual syringe applicator. "There are two proteins that are mixed together, much like you would epoxy glue. Then it can applied using a syringe to drop the sealant onto the bleeding surface," she says." Second, the adhesive can be sprayed.
Finally, the adhesive may be put on a sponge. "You can hold it in place with pressure over the area. That method is very effective in controlling large amounts of bleeding," Burks points out.
However, the product should not be used to close large wounds or used in lieu of sutures under those circumstances, she cautions.
An average patient dose in a 2 ml kit costs about $350, she says.
"In the literature, there is no documented transmission of any viral infection from the tissue adhesives currently on the market," she says. "There’s always a risk of viral transmission with any pooled plasma product; however, with fibrin sealant, there’s significantly less than a traditional blood transfusion."
Fibrin sealant is currently available in the United States through two companies: Baxter Healthcare Corp. in Deerfield, IL, distributes the product under the name of Tisseel. Haemacure Corp. in Sarasota, FL, distributes Hemaseel APR. (See sources, at right.)
The other tissue adhesive that has significant implications for same day surgery is Dermabond, which the FDA approved in August.
Unlike fibrin sealant, Dermabond is intended for topical use only — not for deep wounds under the skin, says Dean Toriumi, MD, associate professor in the division of facial plastic and reconstructive surgery in the department of otolaryngology, head and neck surgery at the University of Illinois at Chicago.
"It is much stronger than fibrin sealant, so it can be used to close lacerations and incisions that otherwise would require sutures, staples, or skin strips," says Toriumi, who participated in the clinical trials. However, because it contains some potentially reactive byproducts [such as cyano crylate and formaldehyde], Dermabond shouldn’t be used internally, he adds.
"For deeper wounds, physicians would need to use small sutures beneath the skin surface, but then use Dermabond to hold the top layers of skin together," he explains. "It may be used in place of topical sutures or staple and in conjunction with, but not in place of, subcuticular sutures."
Dermabond also can be used to hold together skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, says Toriumi. However, it should not be used for wounds across areas of high skin tension, such as knuckles, knees, or elbows, unless the joint will be immobilized during the healing process, he says.
"In areas where the skin is tight, such as the palm of the hand, sutures would be better," he says. "It also shouldn’t be used for decubitus ulcers, infected wounds, or in situations where there is a complex crush injury."
Other contraindications include a potential hypersensitivity to cyanocrylate or formaldehyde.
The product, which comes in a single-use applicator packaged in a blister pouch, costs the hospital $24.95 for each vial — enough to treat one patient. "That’s about the cost of high-end sutures," Toriumi says.
However, the product reduces the need for suture kits, wound dressings, anesthetic injections, syringes, and other instruments, he points out. Because it also eliminates the need for a follow-up visit for suture removal, it can reduce overall treatment costs.
Dermabond is a trademark of Ethicon, a John son and Johnson company, and manufactured by Closure Medical Corp. in Raleigh, NC.
Sources
For more information about Fibrin sealant, contact:
• Sandra Burks, RN, Clinical Coordinator, Tissue Health Center, University of Virginia Health Science Center, MR4 Building — Room 3122, Charlottesville, VA 22908. Telephone: (804) 924-5248. Fax: (804) 924-2714. E-mail: [email protected]. Web: http://www.med.virginia.edu/tac/docs/papers/UVAsealant.html.
• Baxter Healthcare Corp., Hyland Division, 1627 Lake Cook Road, Deerfield, IL 60015. Telephone: (800) 423-2090. Fax: (800) 756-4952.
• Haemacure Corp., 2 N. Tamiami Trail, Suite 802, Sarasota, FL 35236. Telephone: (877) 872-4236 or (941) 364-3700. Web: http://www.haemacure.com.
For more information on Dermabond, contact:
• Ethicon, P.O. Box 151, Somerville, NJ 08376. Tele phone: (877) 384-4266. Web: http://www.ethiconinc.com.
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