RALEIGH, N.C., Nov. 23 /PRNewswire/ -- A study appearing this month in
Plastic and Reconstructive Surgery highlights findings from a one-year period
that shows patients treated with DERMABOND* (2-Octyl Cyanoacrylate) Topical
Skin Adhesive experience superior cosmetic outcomes compared to patients
treated with sutures. DERMABOND Adhesive, which can be used to replace
sutures, staples, and adhesive strips for closing certain topical incisions
and lacerations, is the first such product to be approved by the Food and Drug
Administration for the U.S. market.
One hundred and 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. These groups were then randomized to
receive treatment with either DERMABOND Adhesive or sutures.
At one year, photos of the healed wounds were given to two independent
facial plastic surgeons who were unfamiliar with the study design 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 clinical study submitted to the Food and Drug
Administration.
At one-year post-treatment, the facial plastic surgeons' evaluation of the
photos revealed the group that received treatment with DERMABOND Adhesive
received cosmetic outcome ratings superior to the group treated with sutures.
In addition, there were no instances of wound dehiscence, hematoma or
infection.
"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 Dean M. Toriumi, MD, Associate Professor, Division
of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology --
Head and Neck Surgery, University of Illinois at Chicago, and lead author of
the study. "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 adhesive 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. DERMABOND adhesive should be used in conjunction
with, but not in place of, subcuticular sutures, when they are required.
DERMABOND adhesive must not get into the wound or be used below 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 also 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 should not be used on mucosal surfaces or internally.
Physicians should consult the package insert for full information on use.
DERMABOND Topical Skin Adhesive competes in a worldwide market of
approximately 90 million procedures and annual suture and staple sales of
$2.6 billion. In 1996, CLOSURE Medical licensed exclusive worldwide marketing
and distribution rights for DERMABOND Topical Skin Adhesive to ETHICON, INC.,
a subsidiary of Johnson & Johnson (NYSE: JNJ).
CLOSURE Medical (Nasdaq: CLSR)(http://www.closuremed.com) develops,
commercializes and manufactures medical cohesive products for wound closure
based on its proprietary cyanoacrylate technology. CLOSURE's nonabsorbable
products may be used to replace sutures and staples for certain topical wound
closure applications, while its absorbable products can potentially be used as
surgical sealants and cohesives for internal wound closure and management.
Currently marketed products include: DERMABOND, CLOSURE's non-absorbable
adhesive used for certain topical wound closure applications marketed and
distributed exclusively by ETHICON, INC., a subsidiary of Johnson & Johnson;
Octyldent(R), used in conjunction with antibiotics to treat adult periodontal
disease; and, Nexaband(R), a line of topical cohesives used in veterinary
wound closure and management.
* DERMABOND is a trademark of Ethicon, Inc., a subsidiary of Johnson &
Johnson.
This release contains certain forward-looking statements which involve
known and unknown risks, delays, uncertainties or other factors not under the
Company's control which may cause actual results, performance or achievements
of the Company to be materially different from the results, performance, or
other expectations implied by these forward-looking statements. These factors
include, but are not limited to, scale-up of manufacturing processes;
technological uncertainties; competition from other products; dependence on
marketing partners; and dependence on patents and trade secrets, as well as
those detailed in the Company's Annual Report on Form 10-K for the year ended
December 31, 1997 and filed with the Securities and Exchange Commission.
SOURCE CLOSURE Medical Corporation
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Related links:
http://www.closuremed.com
CONTACT:
Robert V. Toni, President & CEO, or J. Blount
Swain, CFO, both of CLOSURE Medical Corp., 919-876-7800; or Media
Info., Julie Gilman of Golin Harris International, 312-729-4216;
or General Info., Paul G. Henning, or Analyst Info., Brian Gill,
212-661-8030, both of The Financial Relations Board
NOTE TO EDITORS: FOR FULL PRESCRIBING INFORMATION, PLEASE CALL
312-729-4216. To receive CLOSURE's latest news release and other
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Use Company's ticker -- CLSR.
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