72014019

Indications, Safety, and WarningsIndications LiquiBand®* XL is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.LiquiBand®* XL should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.Contraindictions

Do not use on any wounds with evidence of infection or gangrene, or on wounds of decubitus etiology.

Do not use on mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips), or on skin that 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, formaldehyde, benzyltributyl ammonium bromide, or pressure-sensitive adhesive.

Warnings

LiquiBand®* XL incorporates a fast-setting liquid adhesive capable of adhering to most body tissue and to many other materials, such as surgical 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 the liquid adhesive component may be accelerated by water or fluids containing alcohol. LiquiBand®* XL should not be applied to wet wounds.

LiquiBand®* XL should not be applied to the eye. If contact of the liquid adhesive with the eye occurs, flush the eye copiously with saline or water. If residual liquid adhesive remains, apply topical ophthalmic ointment to help loosen the bond and contact an ophthalmologist.

When closing facial wounds near the eye with LiquiBand®* XL, position the patient so that any run-off of the liquid 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 liquid adhesive into the eye. LiquiBand®* XL will not adhere to skin pre-coated with petroleum jelly. Therefore, avoid using petroleum jelly on any skin area where LiquiBand®* XL is intended to adhere. Use of liquid adhesive near the eye has inadvertently caused some patients’ eyelids to be sealed shut. In some of these cases, general anesthesia and surgical removal has been required to open the eyelid.

LiquiBand®* XL should not be used below the skin because the polymerized material is not absorbed by tissue and can elicit a foreign body reaction.

LiquiBand®* XL should not be used in high skin tension areas or across areas of increased skin tension, such as joints, unless the area 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 LiquiBand®* XL.

LiquiBand®* XL 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.

LiquiBand®* XL should not be used on wound sites that will be subjected to repeated or prolonged moisture or friction.

LiquiBand®* XL 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 ensure adequate cleansing and debridement.

Excessive pressure of the applicator tip against the wound edges or surrounding skin can force the wound edges apart and allow liquid adhesive into the wound. Liquid adhesive within the wound could delay wound healing or result in adverse cosmetic outcome, or both. Therefore, the LiquiBand®* XL liquid adhesive component should be applied with a very light brushing motion of the applicator tip over the mesh and surrounding skin area.

LiquiBand®* XL liquid adhesive polymerizes through an exothermic reaction in which a small amount of heat is released. With the proper technique of applying LiquiBand®* XL liquid adhesive in a single layer onto a dry wound, heat is released slowly and the sensation of heat or pain experienced by the patient is minimized. However, if LiquiBand®* XL liquid adhesive is applied so that large droplets of liquid are allowed to remain unspread, the patient may experience a sensation of heat or discomfort.

LiquiBand®* XL is packaged for single patient use. Discard remaining opened material after each wound closure procedure.

Do not resterilize LiquiBand®* XL. Reuse of this device (or portions of this device) may create a risk of product degradation and/or cross-contamination, which may lead to product failure or infection or transmission of bloodborne pathogens to patients and users.

Do not place LiquiBand®* XL in a procedure pack/tray that is to be sterilized prior to use without prior written authorization from manufacturer. Exposure of LiquiBand®* XL 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.

Only for use on adults up to a combined total of 88 cm of mesh and liquid adhesive on a single patient and children (14 kg) up to a combined total of 22 cm of mesh and liquid adhesive on a single patient.

Precautions

Do not apply liquid or ointment medications, or other substances, to the wound after closure with LiquiBand®* XL, as these substances can weaken the polymerized film and allow for wound dehiscence. LiquiBand®* XL permeability by topical medications has not been studied. Prior to application, cleanse the application site thoroughly to remove any remaining blood, fluids, or topical medications/anesthetics.

LiquiBand®* XL permeability by fluids is not known and has not been studied.

LiquiBand®* XL liquid adhesive, as a liquid, is slightly more viscous than water. To prevent inadvertent flow of liquid adhesive to unintended areas, the wound should be held in a horizontal position, with LiquiBand®* XL liquid adhesive applied from above. Any excess liquid adhesive can be quickly wiped off with sterile gauze. If unintended bonding of intact skin with the adhesive should occur, removal may be accomplished by using either acetone or petroleum jelly. Typical cleansers such as soap and other agents such as water, saline, Betadine®, or chlorhexidine gluconate are not expected to loosen the bond. Peel, do not pull skin apart.

If unintended bonding of intact skin with the adhesive should occur, removal may be accomplished by using either acetone or petroleum jelly. Typical cleansers such as soap and other agents such as water, saline, Betadine® or chlorhexidine gluconate are not expected to loosen the bond. Peel, do not pull skin apart.

Safety and effectiveness of LiquiBand®* XL 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 LiquiBand®* XL 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 LiquiBand®* XL and then exposed for prolonged periods to direct sunlight or tanning lamps have not been studied.

Safety and effectiveness of LiquiBand®* XL liquid adhesive on wounds in vermilion surfaces have not been studied.

LiquiBand®* XL should be used immediately after crushing the glass ampoule as the liquid adhesive will not flow freely from the applicator tip after a few minutes.

Hold the applicator away from yourself and the patient and break the ampoule using the wings. Do not crush the contents of the applicator tube repeatedly as excessive manipulation of the applicator may cause glass shard penetration.

Adverse reactionsClinical use of cyanoacrylate with adjunct wound closure devices has suggested that the following adverse events may occur:

Infection (redness more than 3 to 5 mm from the wound margin, swelling, purulent discharge, pain, increased skin temperature, fever)

Acute inflammation (erythema, edema, drainage, pain, warmth)

Dehiscence

Bleeding

Skin edge necrosis

Excessive itching

Skin blistering

Seroma

Hematoma

Bonding to unintended tissues such as the eye

Thermal discomfort during polymerization

Allergic reaction

Foreign body reaction

Chronic non-healing of a wound

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Customer Care Team