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GluStitch® Monograph

NOTE: THE OUTER SURFACE OF THE APPLICATOR SHOULD BE COLD STERILIZED BEFORE USING, ESPECIALLY IF BEING USED IN A STERILE FIELD.

» Indications
In Canada GluStitch® is indicated for the closure of uncomplicated skin lacerations where there is little or no tissue loss. Cyanoacrylate tissue adhesive is also a viable adjunct to traditional therapies in the treatment of "polar hands" and fissured skin.1 GluStitch® should be used under the direction of a physician. TOPICAL USE ONLY. APPOSE WOUND EDGES AND APPLY ALONG THE SURFACE.

» Description
GluStitch® is the n-butyl ester of the cyanoacrylate series. This compound which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions [in the presence of water].

» Method
Unit of Use Kit: Prepare the wound for closure by disinfecting, removing foreign bodies, and examining to rule out underlying damage. The area should be dried, and hemostasis achieved. Hold the applicator in a vertical position, and tap the tip lightly to move glue away from the tip. Clip off the top and gradually lower the tip to move the adhesive into position. Take care not to apply pressure while doing so to avoid inadvertent expelling of the adhesive.

Skin edges should be accurately apposed and slightly everted. A very thin film of glue should be applied over the closely approximated skin edges by squeezing the applicator and producing microdroplets. The skin edges should be kept apposed for at least 30 seconds to allow maximum polymerization. Additional coats may be applied to increase the tensile strength. The polymerization time is only 10 seconds therefore caution must be used to adapt the surfaces exactly. Areas under tension should be reinforced using splints or tapestrips.

Care must be taken that no instruments, cloths, swabs, or gloves come in contact with the adhesive as they will adhere to the surface being glued. Instruments which have been contaminated with adhesive should be cleaned with dimethyl formamide or acetone. If too much adhesive has been inadvertently applied, it can be removed in the first few seconds using a dry swab. Misalignment can be corrected by picking off the glue with forceps and starting again. Vaseline or petrolatum may be of use to remove adhesive from unwanted areas.

» Opening
Multiuse (regular): Squeeze the sides of the cap on the smooth surfaces and twist. The cap has a pin embedded in the top to ensure viability.

» Minikit: Holding the vial upright, remove the protective cap and pierce the top with the T-pin provided. If the removal of the pin becomes difficult, remove the plug at the opposite end with a dry paper towel and withdraw using a pipette. Replace when complete.

Once opened, drop the required amount of adhesive into one of the wells in the tray provided. Using one of the pipettes provided, draw up and apply the adhesive to the surface being treated.2

» Closing and Storage
Minikit: Once opened, the vial should be resealed using the T-pin provided. Ensure that the pin is clean and dry. Do not allow the pin to dwell in the adhesive as it may precipitate polymerization. Store upright in the freezer or refrigerator. Multiuse (regular): Ensure that the tip and cap are clean and dry by removing excess adhesive with a dry paper towel. Replace the cap and store in freezer or refrigerator.

» Important Recommendations
Ideally, GluStitch® should be stored below 5° C. or 40° F. Refrigeration is important to keep the product viable. Whenever the adhesive is used, care must be taken that none splashes onto the cornea of the eye or into the conjunctival sac, where it would cause adhesions. When treating lacerations near the eye, the periorbital area should be protected using gauze or eye shields.
Hemostasis is important since excess blood may cause an intense exothermic reaction [pain!], and may prevent proper tissue adhesion.
Polymerization of GluStitch® produces heat. This is insignificant as long as the adhesive is applied in a very thin film.

» Multiuse Kits:
Only adhesive of a thin, liquid consistency should be used. The condition of the adhesive should be assessed before opening the vials.

» Contraindications
GluStitch® is intended for external use only. GluStitch® must not come into contact with the conjunctival sac since conglutination may occur.

» Supplied:
MiniKit: one x 1 mL. cyanoacrylate, 20 pipettes, multiwell administration tray, T-sealing pin.

» Multiuse Kit: (regular): one x 5 mL. cyanoacrylate, 50 pipettes, multiwell administration tray.

» Unit of Use Kit: twelve x 0.2 mL. cyanoacrylate
All kits are available in clear or with violet surgical coloring.

1. Polar Hands: Spontaneous skin fissures closed with cyanoacrylate [Histoacryl Blue] tissue adhesive in Antarctica. Jeffrey M. Ayton, Polar Medicine, Australian Antarctic Division, Kingston, Tasmania, Australia, Arct Med Res 1993; 52: 127-130. 2. N-2-Butylcyanoacrylate: Risk of Bacterial Contamination with an Appraisal of its Antimicrobial Effects, James V. Quinn et al., J. Emerg. Med 1995: 13. No. 4. Pp 581-585.
Download Product Options & Monograph pdf format

» Files available for viewing & printing:
GluStitch® Product Options
Material Safety Data Sheet

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