Organogenesis, Inc

Organogenesis, Inc Drugs

• Gintuit
  

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  Gintuit

  

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  For topical application in the oral cavity only

  2.1 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.

  2.2 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.

  2.3 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.

  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 plastic insert (see Figure 1) Figure 1: GINTUIT, as supplied Using a sterile blunt instrument, gently tease approximately 0.5 inches (1.3 centimeters) of GINTUIT away from the wall of the plastic insert (see Figure 2). Be careful not to perforate or lift the polycarbonate base beneath GINTUIT. The polycarbonate base should remain attached to the plastic insert. Figure 2:Teasing GINTUIT away from the wall of the plastic insert With sterile gloved hands, insert either one index finger or a sterile blunt instrument under the released section of GINTUIT (see Figure 3). Use another finger or sterile blunt instrument to grasp GINTUIT in a second spot along the edge. Holding GINTUIT in two places, lift the entire GINTUIT out of the plastic insert using a smooth, even motion to prevent GINTUIT from bending and folding over onto itself. Figure 3: GINTUIT being lifted off the polycarbonate base Place GINTUIT on the inner surface of the tray lid, maintaining the proper orientation (upper layer facing up) (see Figure 4). Handle GINTUIT by its edge to minimize damage. Figure 4: GINTUIT placed in the inner surface of the upper tray lid Following removal of GINTUIT from the plastic insert, lift the plastic insert that contains the polycarbonate base from the bottom tray to ensure that this base is intact (see Figure 5a - intact polycarbonate base, and Figure 5b - torn polycarbonate base). Verify that pieces of this base are not removed and accidently applied to the patient. Figure 5:(a) Intact polycarbonate base and (b) torn polycarbonate base Fold GINTUIT into a “z-fold” resulting in the upper layer exposed on the top side and the bottom layer exposed at the bottom side using either sterile gloved hands or sterile blunt instruments (see Figure 6).Note: Do not allow GINTUIT to fold or wrinkle upon itself. If needed, add sterile saline or another physiological salt solution to GINTUIT in the tray lid to facilitate folding. Do not use water. Figure 6:Folding GINTUIT Trim GINTUIT with surgical scissors to the size needed for the surgical site. Use a sterile periodontal probe or other blunt instrument to stabilize the “z-folded” GINTUIT while trimming (see Figure 7). Figure 7: Trimming GINTUIT Place the lower layer (i.e., fibroblast/extracellular matrix side) of GINTUIT in direct contact with the surgical site so that there are no pockets or wrinkled edges (see Figure 8). If needed, use saline to smooth wrinkles. Figure 8: Placement of GINTUIT on the surgical wound bed Immobilize and attach GINTUIT to the surgical mucosal defect with sutures placed at the papillae and apically at each corner. If necessary, add a central suture at the apical margin or lateral margins. Use a crisscross (i.e., suspensory or sling) suture over GINTUIT to enhance stability and help maintain direct contact with the wound bed. GINTUIT must not move during mucosal or muscle traction. Tension may cause GINTUIT to tear. If possible, to help protect GINTUIT, place an additional layer of GINTUIT, extending laterally beyond the defect margins over the “z-folded” GINTUIT, and suture at the four corners. The bottom side (i.e., fibroblast/collagen side) of this additional layer should be in contact with the previously applied “z-folded” GINTUIT. Place a non-occlusive protective dressing over the treated site.

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