GLUture Topical Tissue Adhesive

Topical Tissue Adhesive

Description

GLUture topical tissue adhesive (60% 2-octyl and 40% N-butyl cyanoacrylate) contains a thickener and stabilizers. GLUture topical tissue adhesive is a purple formulation that has been demonstrated to be useful for skin closure in spays, neuters, declaws and other soft tissue surgeries.

How Supplied

GLUture topical tissue adhesive (60% 2-octyl and 40% N-butyl cyanoacrylate) is supplied in individual packages, with each package containing:

● One 1.5 mL multi-use aluminum tube

● Self-piercing tip with purple cap

● Disposable pipette tips

● Package insert

STORAGE CONDITIONS:

Store GLUture topical tissue adhesive at room temperature (below 30°C, 86°F), away from moisture and direct heat.

GLUture Topical Tissue Adhesive Indications

GLUture topical tissue adhesive is indicated for Veterinary Use Only. GLUture topical tissue adhesive is indicated as a tissue bridge, provided that subcutaneous sutures are used (when appropriate), in the following procedures:

● Spays

● Neuters

● Declaws

● Tumor removals

● Lacerations

● Incisions

ADMINISTRATION:

1. The successful application of GLUture topical tissue adhesive requires proper preparation of the wound site. If antiseptic treatment is desired for the wound site, wash the area with a povidone or chlorhexidine gluconate (4%) solution. Do not use other topical ointments or salves as they may interfere with the formation of the GLUture topical tissue adhesive bandage.

2. Hold the tube in an upright position and screw on the self-piercing tip.

3. Remove purple cap and firmly push disposable pipette tip over the piercing tip.

4. AVOID PLACING THIS PRODUCT IN ANY SUBCUTANEOUS TISSUES. It metabolizes very slowly, which could lead to the development of a foreign body reaction.

5. Topical Skin Closure (See Below for Declaw Procedure)

a. The normal surgical procedure should be followed with the exception of the skin-closing step. Subcutaneous tissue should be closed with absorbable suture, resulting in a tension-free wound. Incisions with high physical stress may require suturing.

b. Suture the subcutaneous tissue to approximate the skin edges as closely as possible minimizing exposed subcutaneous tissue between skin edges. If gaps in the primary tissue closure are apparent, press the skin edges together with gloved fingers or sterile forceps while slowly applying the GLUture topical tissue adhesive. Remove as much blood as possible from the incision site by blotting.

c. Hold the pipette tip slightly above the incision line and gently squeeze the adhesive from the tube in a thin line to the surface of the approximated skin edges. The product will be clear when dry. DO NOT FILL THE WOUND CAVITY WITH THE PRODUCT.

d. The wound edges need to be manually apposed for approximately 1 minute or until adequate wound strength is achieved. Full polymerization is expected when the top layer of GLUture topical tissue adhesive is no longer tacky.

6. Topical Skin Closure for Declaw Procedure

a. Prepare surgical site as usual and remove the third phalanx using your routine surgical procedure.

b. Remove as much blood as possible from incision site by blotting.

c. Hold incised skin edges together and gently squeeze adhesive from the tube to the surface of the skin incision - apply enough to ensure adhesion. DO NOT FILL THE WOUND CAVITY WITH THE PRODUCT. Extend the GLUture topical tissue adhesive slightly onto normal skin at both ends of the wound. Do not glue hair into the wound.

1. Apply GLUture topical tissue adhesive to form a thin line, the product will be clear when dry.

2. Do not place GLUture topical tissue adhesive in the wound cavity as it may cause a foreign body reaction.

d. Press skin edges together with forceps and hold for 5 to 10 seconds.

e. After completing the procedure, check for bleeding and reapply adhesive to the skin edges if necessary. Sutures are usually not needed.

7. DO NOT APPLY GLUture topical tissue adhesive OVER A POOL OF BLOOD OR FLUID. This will cause improper polymerization and adherence to the skin, resulting in the premature sloughing of the GLUture topical tissue adhesive.

8. After use, wipe the tube with a non-cotton wipe prior to replacing cap.

Contraindications

GLUture topical tissue adhesive is contraindicated in the management of infected or deep puncture wounds. GLUture topical tissue adhesive is not intended to be used as a replacement for suture material that would normally be used subcutaneously (i.e. absorbable sutures).

PRECAUTIONS/WARNINGS:

● Placing this product in any subcutaneous tissues may lead to a foreign body reaction and potential wound separation.

● Avoid unintended placement on skin and eyes.

● Avoid contact with surgical instruments and apparatus (such as gloves).

● After use, remove disposable pipette tip and discard.

● Use a new disposable tip for each procedure.

● Before replacing the screw-top cap, wipe excess adhesive from the piercing tip with an absorbent lint-free wipe to prevent cap from sticking.

● The product should not be used beyond the indicated expiration date.

REMOVAL OF GLUture TOPICAL TISSUE ADHESIVE:

GLUture topical tissue adhesive can be removed from skin or other surfaces with acetone.

ACTION:

GLUture topical tissue adhesive is a 60% 2-octyl and 40% N-butyl cyanoacrylate formulation, which, upon contact with most bodily fluids or with an alkaline pH environment, polymerizes to form a thin, flexible, waterproof bridge/bandage. When GLUture topical tissue adhesive is used along an approximated surgical incision, the initial contact of the product will rapidly polymerize at the tissue junction. The remaining material that forms the tissue bridge will polymerize at a slower rate. The formation of the tissue bridge holds the approximated wound edges together.

Tissue regeneration and wound healing occurs under the GLUture topical tissue adhesive layer and is sloughed naturally as the incision heals.

TECHNICAL SUPPORT:

To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com.

Manufactured for Zoetis Inc., Kalamazoo, MI 49007

A1-0006/R1

CPN: 3690508.2