Vet BioSISt (Canada)

Manufacturer: Smiths-SurgiVet^®

Tissue Repair Sheet

Composition

VET BioSISt™ Tissue Repair Sheets and Ocular Discs are composed of a naturally-occurring biocompatible matrix. The single layered lyophilized sheets are derived from the submucosal layer of the porcine small intestine, which has been disinfected to eliminate bacteria and inactivate viruses. This natural material contains collagen (Types I, III, and IV), fibronectin, decorin, hyaluronic acid, chondroitin, heparan sulphate, and growth factors (TGFβ, FGF-2, and CTGF).

Vet BioSISt Indications

VET BioSISt™ is for use as a surgical patch for soft tissue repair or reinforcement. It promotes wound healing and tissue repair by providing a biocompatible, remodelable scaffold for tissue ingrowth. It is suitable for dermal tissue repair applications where the skin cannot be sutured together or when subdermal tissues are damaged. Other potential applications of this surgical patch include repairs of internal organs, cleft palate, periodontal tissue, and corneal ulcerations. VET BioSISt™ has also been used in surgery as a fistula plug, a suture reinforcement sheet, and a hemostatic plug.

Vet BioSISt Dosage And Administration

Suggested Instructions for Use: Always handle VET BioSISt™ using sterile technique.

1. Prepare wound area using standard methods to insure wound is free of debris and necrotic tissue. Debride the wound to insure the wound edges contain viable tissue. When necessary, it is recommended that VET BioSISt™ is not applied until excessive exudate, bleeding, acute swelling and infection are controlled.

2. To apply, cut the dry sheet with sterile scissors into a patch slightly larger than the outline of the wound area.

3. Rehydrate the VET BioSISt™ patch by placing it in a bowl of sterile saline or other isotonic solution for at least one (1) minute before placing the patch over the wound surface. In dermal applications, place the edge of the patch under the edge of the intact tissue to encourage tissue overgrowth during wound healing.

4. Secure the patch to the wound edges using 3.0 or 4.0 sutures or small surgical clips. In large area wounds, multiple sheets may need to be used and several evenly spaced sutures may be placed through the patch and into the wound bed to enhance overall contact between the tissue and the patch. If excess exudate collects under the patch, small openings can be cut in the patch to allow the exudate to drain. Use an appropriate dressing to maintain a moist wound environment. The optimum dressing is determined by wound location, size, depth, and surgeon preference. For external wounds, it is recommended that the VET BioSISt™ patch be covered with an aqueous gel (such as aloe vera gel or KY Jelly) and then a non-adhesive dressing (Melolin or soft gauze would suffice). Cover this dressing with a dry exterior dressing that will protect the wound and maintain internal moisture. The bandage should not be interfered with until the 5th day. Leave the moist interior dressing undisturbed for at least three (3) days or until the VET BioSISt™ patch begins to be absorbed into the underlying tissue. The VET BioSISt™ patch should not be removed.

The Healing Process: A General Guide - The first 5 (five) days are the “golden period” where tissue ingrowth and angiogenesis occur. When the bandage is removed on day 5, the wound should be irrigated with normal saline and then recovered with aqueous gel, soft gauze and adhesive bandage. Successful treatment with VET BioSISt™ may form a “caramel-colored” gel - leave the gel intact.

By day 10, the healing process should be well underway with the graft having been overtaken by new tissue growth. Epithelialization will also be occurring. The re-bandaging process should be repeated (using aqueous gel).

By day 20, it may be possible to leave the wound open to air, but should you decide to keep it bandaged, this will not retard the healing process.

Vet BioSISt Caution(s)

VET BioSISt™ is not for use in humans or in vitro diagnostics.

Initial application of this product may produce mild, localized inflammation. If this condition worsens or persists beyond five (5) days, the product should be removed. If noticeable wound infection occurs, appropriate oral antibiotic therapy should be administered. If infection persists, the product should be removed and the wound should be surgically debrided. When used in high pressure applications, sheets may need to be placed in multiple layers to provide adequate strength. This product is derived from a porcine source. Animals with known sensitivity to porcine material should not be exposed to this product.

Storage

VET BioSISt™ sheets are stable for 24 months when kept dry and stored in the original, unopened packaging at room temperature. Sterility: Supplied sterile in easy open packages, for one-time use. Re-sterilization of this product will result in product degradation.

Distributed By

Veterinary distributors or contact Smiths Medical North America at 888-745-6562.

V-BSRS1099

Presentation

Available Products: Product is packaged in double peel-pouches and supplied sterile, for one time use.

Single layer sheet is available as 70 mm x 100 mm (Catalog # VB0710).

Twin pack 40 x 70 mm, 2 sealed sheets per pack (Catalog # VB0704S2).

Multi laminate sheet is 70 mm x 100 mm and is used for internal hernia repairs. The surface characteristics of both sides of the multi laminate sheet are the same (Catalog # VB07104L).

Ocular Disc: Ocular discs are packaged in double peel-pouches with the rough side indicated by a notch. Experiments have shown that cell ingrowth increases if the rough side is placed against the wound. Each disc is 10 mm or 15 mm in diameter. Four individual discs are supplied sterile in sealed sections of easy open packages, for one time use (Catalog # VB10D4 and VB15D4).

Nac No.

13260001