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News of Interest FDA Approves Use Of DERMABOND Adhesive To Seal Out Infection-Causing BacteriaFirst Wound-Closure Technology Approved To Protect Wounds & Incisions From Common Microbes SOMERVILLE, NJ -- (INTERNET WIRE) -- 01/16/2002 -- ETHICON Products announced today that DERMABOND* Topical Skin Adhesive (2-octyl cyanoacrylate) can act as a barrier against bacterial microbes. The microbial barrier provided by DERMABOND Adhesive seals out the most common infection-causing bacteria, including certain staph, pseudomonas and E. coli. DERMABOND Adhesive is a liquid topical skin adhesive that can be used to close surgical incisions and traumatic lacerations without stitches or staples. DERMABOND Adhesive acts as a barrier to microbial penetration as long as the adhesive film remains intact, according to new labeling approved by the U.S. Food and Drug Administration (FDA). “For trauma and post-surgical patients, infections are often the most common, and in some cases, the most serious complications,” said Ronald Lee Nichols, M.D., the William Henderson Professor of Surgery, Professor of Microbiology and Immunology affiliated with Tulane University, New Orleans. “Doctors are looking for ways to help people heal more comfortably and completely, and the bacteria-blocking properties of DERMABOND Adhesive clearly may assist the recovery of their patients.” In in vitro studies, DERMABOND Adhesive was 99 percent effective in protecting against the following bacteria: Staphylococcus epidermidis, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Enterococcus faecium. Product labeling has been changed to include information about its ability to act as a microbial barrier. Studies Demonstrate Excellent Cosmetic Results, Less Pain & Lower Costs Research studies have concluded that wounds and incisions treated with DERMABOND Adhesive lead to excellent cosmetic results, similar to those of suturing, while providing patients with a fast and relatively painless closure(1). In studies, patients receiving DERMABOND Adhesive were less likely to require anesthesia, did not require the physicians to wait for the onset of anesthesia, and had faster wound closure times(2). In one study, the mean time to closure by physicians was nearly 12.5 minutes with sutures and only 3.6 minutes using DERMABOND Adhesive(3).
A cost-effectiveness analysis comparing the costs of wound repair using tissue adhesives and sutures demonstrated significant cost savings using DERMABOND Adhesive. These cost savings were the result of reduced physician and ancillary services, fewer surgical supplies and reduced equipment needs, and elimination of the need for suture removal(4). In addition, because DERMABOND Adhesive does not use needles, the threat of needle stick injury is eliminated for healthcare professionals. How DERMABOND Adhesive Works DERMABOND Adhesive is a liquid applied topically to the easily approximated edges of a laceration or incision – skin edges that can be placed directly against each other. It can be used in conjunction with, but not in place of, subcuticular sutures. When closing a wound, the physician first cleans the laceration or incision, then holds its edges together and applies the adhesive to the skin using a light, brushing stroke, repeating this three times. In less than three minutes, DERMABOND Adhesive provides the strength of healed tissue at seven days. The product also provides a moist wound-healing environment, which promotes quicker and more complete healing. DERMABOND Adhesive naturally sloughs off the skin in five to ten days. “More than three years of clinical use have clearly demonstrated that DERMABOND Adhesive is an effective wound-closing technology that creates a strong bond,” continued Dr. Nichols. “Unlike earlier tissue adhesives, patients do not need to worry about the strength of DERMABOND Adhesive’s closure, and, cosmetically, lacerations or incisions closed with this product look equal to and often better than those closed with traditional sutures or staples.” Approved by the FDA in 1998, DERMABOND Adhesive has been used extensively by health professionals in the fields of trauma, plastic and other surgeries, emergency medicine, and pediatrics. Since its approval, DERMABOND Adhesive has proven useful in closing surgical incisions where suture removal can cause significant discomfort. The adhesive does not produce suture or “track” marks along the healed incision and unlike stitches, a patient can shower right away without fear of compromising the incision. DERMABOND Adhesive is contraindicated for use on any wounds with evidence of active infection or gangrene. It should also not be used on mucosal surfaces or across mucocutaneous junctions (e.g., lips, oral cavity), or on skin that is regularly exposed to body fluids or with dense hair (e.g., scalp). DERMABOND Adhesive should not be used on patients with a known hypersensitivity to cyanoacrylate or formaldehyde. For more information visit www.DERMABOND.com. DERMABOND Adhesive is licensed by ETHICON from Closure Medical Corporation, based in Raleigh, North Carolina. ETHICON Products, a division of ETHICON, INC., a Johnson & Johnson company, continues Johnson & Johnson’s 100-year commitment to wound care today with inventive products for wound closure and cardiovascular surgery. ETHICON Products is the worldwide leader in suture products and suture technology, and is one of the most recognizable and well-respected brand names in the hospital environment. The division has a long history of innovation in providing products – including sutures, topical adhesives, surgical meshes and wound drains – that enhance patient care. Pioneering cardiovascular products include surgical devices that restore and improve the circulatory health and quality of life for people with cardiovascular disease. For more information about ETHICON Products, or other ETHICON divisions, visit www.ethiconinc.com. * Trademark 1 J Quinn, G Wells, T Sutcliffe, et al. A Randomized Trial Comparing Octyl Cyanoacrylate Tissue Adhesive and Sutures in the Management of Lacerations. Journal of the American Medical Association. Vol 277, no.19, 1527-1530. 2 AJ Singer, JE Hollander, SM Valentine, et al. Prospective, Randomized, Controlled Trial of Tissue Adhesive (2-Octyl Cyanoacrylate) vs. Standard Wound Closure Techniques for Laceration Repair. Presented at the 2000 annual meeting for the Society for Academic Emergency Medicine. 3 JAMA. 4 Osmond MH, Klassen TP, Quinn JV. Economic comparison of a tissue adhesive and suturing in the repair of pediatric facial lacerations. J Pediatrics. 1995; 126:892-5.
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