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WOUND PREPARATION
D E R M A B O N D* T O P I C A L S K I N AD H E S I V E
APPLICATION TECHNIQUE
Remove the applicator
system from the package.
Hold horizontally and
twist the collar.
Align the hatch marks. Press the pad on the side to
express adhesive. Apply 2
thin layers of adhesive,
waiting approximately
30 seconds between layers.
Follow standard surgical practice for wound preparation and achieve hemostasis
APPLICATION WITH
DERMABOND PROPEN ADHESIVE SYSTEM
APPLICATION WITH DOME TIP APPLICATOR
1 2 3 4
1
Crack the DERMABOND 2adhesive vial in the upright
position, invert, and apply
pressure to saturate the tip.
Release pressure, then
reapply pressure to express
adhesive.
Apply 2 thin layers
of adhesive, waiting
approximately 30
seconds between layers.
For more information visitwww.dermabondtraining.com
High Viscosity
Topical Skin Adhesive
(2-Octyl Cyanoacrylate)
INDICATIONS
High viscosity DERMABOND Topical Skin Adhesive is intended for topical application only to hold
closed easily approximated skin edges of wounds from surgical incisions, including punctures
from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.
High viscosity DERMABOND adhesive may be used in conjunction with, but not in place of, deep
dermal stitches.
CONTRAINDICATIONS
• Do not use on any wound with evidence of active infection, gangrene, or wounds of decubitus
etiology.
• Do not use on mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips), or
on skin which may be regularly exposed to body fluids or with dense natural hair, (e.g., scalp).
• Do not use on patients with a known hypersensitivity to cyanoacrylate or formaldehyde.
WARNINGS
• High viscosity DERMABOND adhesive is a fast setting adhesive capable of adhering to most
body tissue and many other materials, such as latex gloves and stainless steel. Inadvertent
contact with any body tissue, and any surfaces or equipment that are not disposable or that
cannot be readily cleaned with a solvent such as acetone should be avoided.
• Polymerization of high viscosity DERMABOND adhesive may be accelerated by water or fluids
containing alcohol: High viscosity DERMABOND adhesive should not be applied to wet wounds.
• High viscosity DERMABOND adhesive should not be applied to the eye. If contact with the eye
occurs, flush the eye copiously with saline or water. If residual adhesive remains, apply topical
ophthalmic ointment to help loosen the bond and contact an ophthalmologist.
• When closing facial wounds near the eye with high viscosity DERMABOND adhesive, position
the patient so that any run-off of adhesive is away from the eye. The eye should be closed and
protected with gauze. Prophylactic placement of petroleum jelly around the eye, to act as a
mechanical barrier or dam, can be effective in preventing inadvertent flow of adhesive into the
eye. High viscosity DERMABOND adhesive will not adhere to skin pre-coated with petroleum
jelly. Therefore, avoid using petroleum jelly on any skin area where high viscosity DERMABOND
adhesive is intended to adhere. Use of DERMABOND adhesive near the eye has inadvertently
caused some patient’s eyelids to be sealed shut. In some of these cases, general anesthesia and
surgical removal has been required to open the eyelid.
• High viscosity DERMABOND adhesive should not be used below the skin because the polymerized
material is not absorbed by tissue and can elicit a foreign body reaction.
• High viscosity DERMABOND adhesive should not be used in high skin tension areas or across
areas of increased skin tension, such as knuckles, elbows, or knees, unless the joint will be
immobilized during the skin healing period or unless skin tension has been removed by application
of another wound closure device (e.g., sutures or skin staples) prior to application of
high viscosity DERMABOND adhesive.
• High viscosity DERMABOND adhesive treated wounds should be monitored for signs of
infection. Wounds with signs of infection, such as erythema, edema, warmth, pain and
pus, should be evaluated and treated according to standard practice for infection.
• High viscosity DERMABOND adhesive should not be used on wound sites that will be subjected
to repeated or prolonged moisture or friction.
• High viscosity DERMABOND adhesive should only be used after wounds have been cleaned,
debrided and are otherwise closed in accordance with standard surgical practice. Local anesthetic
should be used when necessary to assure adequate cleansing and debridement.
• Excessive pressure of the applicator tip against wound edges or surrounding skin can force
the wound edges apart and allow adhesive into the wound. Adhesive within the wound could
delay wound healing and/or result in adverse cosmetic outcome. Therefore, high viscosity
DERMABOND adhesive should be applied with a very light brushing motion of the applicator tip
over easily approximated wound edges.
• High viscosity DERMABOND adhesive polymerizes through an exothermic reaction in which a
small amount of heat is released. With the proper technique of applying high viscosity
DERMABOND adhesive in multiple thin layers (at least two) onto a dry wound and allowing time
for polymerization between applications, heat is released slowly and the sensation of heat or
pain experienced by the patient is minimized. However, if high viscosity DERMABOND adhesive
is applied so that large droplets of liquid are allowed to remain unspread, the patient may experience
a sensation of heat or discomfort.
• High viscosity DERMABOND adhesive is packaged for single patient use. Discard remaining
opened material after each wound closure procedure.
• Do not resterilize high viscosity DERMABOND adhesive.
• Do not place high viscosity DERMABOND adhesive in a procedure pack/tray that is to be
sterilized prior to use. Exposure of high viscosity DERMABOND adhesive, after its final manufacture,
to excessive heat (as in autoclaves or ethylene oxide sterilization) or radiation (such
as gamma or electron beam), is known to increase its viscosity and may render the product
unusable.
PRECAUTIONS
• High viscosity DERMABOND adhesive has not been evaluated for use on wounds such as surgical
incisions, punctures from minimally invasive surgery.
• Do not apply liquid or ointment medications or other substances to the wound after closure
with high viscosity DERMABOND adhesive, as these substances can weaken the polymerized
film and allow for wound dehiscence. High viscosity DERMABOND adhesive permeability by
topical medications has not been studied.
• High viscosity DERMABOND adhesive permeability by fluids is not known and has not been
studied.
• High viscosity DERMABOND adhesive, as a liquid, is syrup-like in viscosity. To prevent inadvertent
flow of liquid high viscosity DERMABOND adhesive to unintended areas: (1) the wound
should be held in a horizontal position, with high viscosity DERMABOND adhesive applied from
above, and (2) high viscosity DERMABOND adhesive should be applied in multiple (at least
two), thin layers rather than in a few large droplets.
• Hold applicator away from yourself and the patient and break ampule close to its center one
time only. Do not crush the contents of the applicator tube repeatedly as further manipulation
of the applicator may cause glass shard penetration of the outer tube.
• High viscosity DERMABOND adhesive should be used immediately after crushing the glass
ampule as the liquid adhesive will not flow freely from the applicator tip after a few minutes.
• If unintended bonding of intact skin occurs, peel, but do not pull the skin apart. Petroleum jelly
or acetone may help loosen the bond. Other agents such as water, saline, Betadine®
Antibiotics, HIBICLENS† (chlorhexidene gluconate), or soap, are not expected to immediately
loosen the bond.
• Safety and effectiveness of high viscosity DERMABOND adhesive on wounds of patients
with peripheral vascular disease, insulin dependent diabetes mellitus, blood clotting disorders,
personal or family history of keloid formation or hypertrophy, or burst stellate lacerations, have
not been studied.
• Safety and effectiveness of high viscosity DERMABOND adhesive on the following wounds have
not been studied: animal or human bites, puncture or stab wounds.
• Safety and effectiveness on wounds that have been treated with high viscosity DERMABOND
adhesive and then exposed for prolonged periods to direct sunlight or tanning lamps have not
been studied.
• Safety and effectiveness of high viscosity DERMABOND adhesive on wounds in vermilion
surfaces has not been studied.
ADVERSE REACTIONS
Adverse reactions encountered during the clinical study for closure of trauma-induced lacerations
using high viscosity DERMABOND adhesive and the clinical study comparing low viscosity
DERMABOND adhesive to sutures, staples, and adhesive strips are listed below:
The safety of both high viscosity DERMABOND adhesive and the low viscosity DERMABOND
adhesive control was measured in a randomized clinical study of 84 patients, 42 patients receiving
high viscosity product and 42 receiving low viscosity product, by 1) the presence or the
extent of an inflammatory reaction, 2) the presence of signs of clinical infection, 3) cosmetic
outcome at Day 30, 4) assessment of thermal discomfort, and 5) the reported adverse events
associated with use of the device. No significant differences between the two treatment groups
were observed for any of these safety outcome measures, although 17 patients (44%) randomized
to the high viscosity DERMABOND adhesive treatment group experienced a sensation of
heat during application of the skin adhesive compared to 10 patients (26%) randomized to the
low viscosity DERMABOND adhesive treatment group. Of those 17 patients in the high viscosity
group, 5 of the patients noted that sensation of heat was uncomfortable. None of the patients in
the low viscosity group observed objectionable sensation of heat.
As indicated under WARNINGS, high viscosity DERMABOND adhesive polymerizes through an
exothermic reaction in which heat is released. It is important to use the proper technique of
applying high viscosity DERMABOND adhesive in thin layers to minimize the risk that the patient
may experience a sensation of heat or discomfort. This is especially important in the application
of high viscosity DERMABOND adhesive, because the increased viscosity of the product relative
to low viscosity DERMABOND adhesive can create a thicker applied layer resulting in a higher
potential for heat to be generated. High viscosity DERMABOND adhesive should always be
applied in thin layers so that large amounts of liquid are not allowed to collect, resulting in
thermal discomfort for the patient.
Adverse reactions encountered during clinical study comparing low viscosity DERMABOND
adhesive to sutures, staples, and adhesive strips are listed in the table below:
Clinical Study No With
Outcomes Subcuticular Subcuticular
Sutures Sutures
DERMABOND Control DERMABOND Control
N (%) N (%) N (%) N (%)
Accounting
N, patients enrolled 240 243 167 168
N, patients treated 239 242 167 166
Patients completed 228 (95%) 215 (88%) 164 (98%) 162 (96%)
Adverse Reactions
Suspected Infection* 8 (3.6%) 2 (0.9%) 6 (3.6%) 2 (1.2%)
Wound type
# Lacerations 8 2 1 0
# Incisions 0 0 5 2
Dehiscence with Need
for Retreatment 6 (2.5%) 5 (2.1%) 3 (1.8%) 0
Acute Inflammation
Erythema 26 (11.5%) 74 (33.0%) 52 (31.3%) 75 (45.1%)
Edema 22 (9.7%) 28 (12.5%) 62 (37.3%) 71 (42.8%)
Pain 14 (6.1%) 13 (5.8%) 56 (33.7%) 57 (34.3%)
Warmth 3 (1.3%) 6 (2.6%) 3 (1.8%) 4 (2.4%)
*In the clinical study, presence of infection was to be identified by observation of redness more
than 3–5 mm from the repaired wound, swelling, purulent discharge, pain, increased skin
temperature, fever, or other systemic signs of infection. Confirmatory culture was not routinely
obtained. Among cases of suspected infection for low viscosity DERMABOND adhesive, 7/14
(50%) were in patients less than 12 years old with traumatic lacerations; overall, 8 of the 14
(approximately 60%) low viscosity DERMABOND adhesive wounds with suspected infections
were associated with sub-optimal cosmetic outcome.
• Reactions may occur in patients who are hypersensitive to cyanoacrylate or formaldehyde. See
CONTRAINDICATIONS.
• Adverse reactions may be experienced following high viscosity DERMABOND adhesive contact
with the eye.
Manufactured for ETHICON, INC.
by Closure Medical Corp.
© ETHICON, INC. 2003
®Trademark of Purdue Fredericks
†Registered Trademark of Zeneca Pharmaceuticals
*Trademark ® ETHICON, INC. 2006
