Warnings & Wound Closure Procedure

Warnings

  • derma+flex® Tissue 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 derma+flex® Tissue Adhesive may be accelerated by water or fluids containing alcohol: derma+flex® Tissue Adhesive should not be applied to wet wounds.
  • derma+flex® Tissue 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.
  • derma+flex® Tissue Adhesive should not be used below the skin because the polymerized material is not absorbed by tissue and can elicit a foreign body reaction.
  • derma+flex® Tissue Adhesive should not be used  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, skin staples, or adhesive wound closure strips) prior to application of derma+flex® Tissue Adhesive.
  • derma+flex® Tissue Adhesive should not be used on wound sites that will be subjected to repeated or prolonged moisture or friction.
  • derma+flex® Tissue Adhesive polymerizes through an exothermic reaction in which a small amount of heat is released. With the proper application technique of derma+flex® Tissue Adhesive any potential sensation of heat or pain experienced by the patient is minimized.
  • derma+flex® Tissue Adhesive is packaged for single patient use. Discard remaining opened material after each wound closure procedure.
  • Do not resterilize derma+flex®  Tissue Adhesive.
  • Do not place derma+flex®  Tissue Adhesive in a procedure pack/tray that is to be sterilized prior to use. Exposure of derma+flex®  Tissue Adhesive, after its final manufacture, to excessive heat (as in autoclaves) or radiation (such as gamma or electron beam), is known to increase its viscosity and may render the product unusable.
  • Potential systemic toxicity of this product is unknown.

Wound Closure Procedure

  • derma+flex® Tissue 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. derma+flex® Tissue Adhesive is best applied with a very light brushing motion of the applicator tip over easily approximated wound edges.
  • When closing facial wounds near the eye with derma+flex® Tissue 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. derma+flex® Tissue Adhesive will not adhere to skin pre-coated with petroleum jelly. Therefore, avoid using petroleum jelly on any skin area where derma+flex® Tissue Adhesive is intended to adhere.
  • derma+flex® Tissue 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.

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