Gintuit

Generic name: allogeneic cultured keratinocytes and fibroblasts in bovine collagen
Dosage form: cellular sheet

Indications and Usage for Gintuit

Gintuit (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.

Gintuit is not intended to provide root coverage.

Gintuit Dosage and Administration

For topical application in the oral cavity only

Dosage

For single patient use only.

Gintuit is used as one application over a surgically created vascular wound bed in the oral cavity. The size of Gintuit is adjusted for the size of the wound bed.

The safety and efficacy of repeat application(s) of Gintuit have not been established.

Preparation

Preparation of the Surgical Site

Following local anesthesia, surgically create a vascular wound bed with viable wound edges and establish adequate hemostasis.

Preparation of Gintuit

• Examine the sealed polybag for any leaks or evidence of damage or contamination.
• Verify the expiration date of Gintuit. The product expires at 11:59 PM ET on the date of expiration.
• Verify that the product pH (6.8-7.7) is within the acceptable range, using the agarose gel medium pH Color Chart.
• Do not open the polybag until the surgical site has been prepared.
• Use Gintuit within 15 minutes of opening the sealed polybag.

Application

• Always handle Gintuit aseptically.
• Do not use Gintuit if there is evidence of contamination, visible particulates, or pungent odor.
• Gintuit, as supplied, is not a biohazardous material; however, follow your local (e.g., institutional or private practice) guidelines for disposal of any remaining Gintuit.

1. Lift off the tray lid and place it on a surgical sterile field with the outer lid surface facing down. Gintuit is packaged with the upper layer (containing keratinocytes that appear dull, with a matte finish) facing up and the lower layer (containing fibroblasts in extracellular matrix that appears glossy) facing down, resting on the polycarbonate base attached to the ...