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Vistaseal Dosage

Generic name: Fibrinogen Human 80mg in 1mL; Thrombin Human 500[iU] in 1mL
Dosage form: injection
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com. Last updated on Oct 1, 2024.

For topical use only.

Dosage

The recommended dose of VISTASEAL is based on the surface area coverage.

The approximate surface area coverage for each VISTASEAL package size is provided in Table 1.

Table 1. Surface Area Coverage
VISTASEAL package size Surface area coverage (cm2)
Application by dripping or spray
(1 mm thick layer)
2 mL 16 - 22
4 mL 32 - 44
6 mL 48 - 66
10 mL 80 - 110

Dose depends on variables including, but not limited to, the type of surgical intervention, the size of the area, the intended application method, and the number of applications.

Apply a sufficient volume of VISTASEAL to entirely cover the intended application area with a thin layer. Repeat the application if necessary.

Preparation and Handling

Prepare and administer the product only according to the instructions and with the recommended devices.

An overview of thawing methods and storage after thawing is provided in Table 2.

Table 2. Thawing and storage after thawing
Thawing method Thawing time per package size Maximum storage time after thawing
For 2 mL and 4 mL For 6 mL and 10 mL
Refrigerator (2 – 8 °C [36 – 46 °F]) Minimum 7 hours Minimum 10 hours 7 days at 2 - 8 °C [36 – 46 °F] (refrigerator) in original package OR 24 hours at 20 - 25 °C [68 - 77 °F] (room temperature) in original package
Room Temperature (20 - 25 °C [68 – 77 °F]) Minimum 70 minutes Minimum 90 minutes 7 days at 2 - 8 °C [36 – 46 °F] (refrigerator) in original package OR 24 hours at 20 - 25 °C [68 - 77 °F] (room temperature) in original package
Sterile water bath set at 37 °C [99 °F] inside sterile field. The water temperature must not exceed 39 °C [102 °F]. Minimum 5 minutes. Do not exceed 10 minutes. Minimum 5 minutes. Do not exceed 10 minutes. Use immediately during the surgery

Preferred thawing methods

Option 1: Refrigerator thawing

  1. Remove carton from freezer and place it unopened in the refrigerator for thawing at 2 – 8 °C [36 – 46 °F] for
    a minimum of 7 hours for the 2 mL and the 4 mL package sizes
    a minimum of 10 hours for the 6 mL and the 10 mL package sizes

After thawing, it is not necessary to warm the product for its use.
After thawing, the solutions must be clear to slightly opalescent, colorless to pale yellow and must not be cloudy nor have deposits.

Option 2: Room Temperature Thawing
Remove carton from freezer, open it and take out the two blisters.
Place the blister containing the VISTASEAL Dual Applicator at room temperature until the VISTASEAL fibrin sealant (human) is ready to use.

Thaw blister with VISTASEAL pre-filled syringes at room temperature using the following steps:

  1. Place the blister containing the syringe holder with pre-filled syringes on a surface at room temperature (20 ºC - 25 ºC, [68 - 77 ºF]) for
    a minimum of 70 minutes for the 2 mL and the 4 mL package sizes
    a minimum of 90 minutes for the 6 mL and the 10 mL package sizes

After thawing, it is not necessary to warm the product for its use.
After thawing, the solutions must be clear to slightly opalescent, colorless to pale yellow and must not be cloudy nor have deposits.

Post-Thawing Storage:
After thawing, the kit containing the VISTASEAL syringe holder with pre-filled syringes and Dual Applicator can be stored before use for not more than 7 days in the refrigerator at 2 ‑ 8 ºC [36 - 46 ºF] or 24 hours at room temperature (20 - 25 °C [68 - 77 ºF]) if it remains sealed in the original packaging. Once the blisters are opened, use VISTASEAL immediately during the surgery and discard any unused contents.
Once thawed, do not refreeze.

Transferring instructions:

  1. After thawing, remove the blister from the surface at room temperature or remove carton from the refrigerator at 2 - 8 °C [36 - 46 ºF] and take out the two blisters.
  2. Open the blister and confirm that the VISTASEAL pre-filled syringes are completely thawed. After thawing, the solutions must be clear to slightly opalescent, colorless to pale yellow and must not be cloudy nor have deposits. Make the VISTASEAL syringe holder with pre-filled syringes available to a second person for transfer to the sterile field. The outside of the blister should not come in contact with the sterile field. See Figure 1.
    Figure 1

    Figure 1

Sterile Water Bath (Quick Thawing) method
Remove carton from freezer, open it and take out the two blisters.
Place the blister containing the VISTASEAL Dual Applicator at room temperature until VISTASEAL fibrin sealant (human) is ready to use.

Thaw VISTASEAL pre-filled syringes inside the sterile field in a sterile thermostatic water bath set at a temperature of 37 °C [99 °F] using the following steps:
NOTE: Prepare and maintain the sterile water bath following the instructions of the water bath manufacturer and according to hospital procedures to maintain a sterile surgical field and avoid the possibility of contamination.
NOTE: Once the VISTASEAL blisters are opened, use the product immediately during surgery. Use sterile technique to avoid the possibility of contamination due to improper handling, and follow the steps below accurately. Do not remove the syringe luer cap until thawing is complete and the Dual Applicator is ready to be attached.

  1. Open the blister and make the VISTASEAL syringe holder with pre-filled syringes available to a second person for transfer to the sterile field. The outside of the blister should not come in contact with the sterile field. See Figure 1.
  2. Place the syringe holder with pre-filled syringes directly into the sterile water bath ensuring that it is completely immersed in the water. See Figure 2.
  3. At 37 ºC, the time needed is approximately 5 minutes for the 2 mL, 4 mL, 6 mL, and 10 mL package sizes, but must not be left at this temperature for longer than 10 minutes.
    NOTE: The temperature of the water must not exceed 39°C. To monitor the water temperature, you may use a thermometer and change the water as necessary.
  4. Dry the syringe holder with pre-filled syringes after thawing, using a sterile surgical gauze.

    Figure 2


    Figure 2

Confirm that the VISTASEAL pre-filled syringes are completely thawed. After thawing, the solutions must be clear to slightly opalescent, colorless to pale yellow and must not be cloudy nor have deposits.
Use VISTASEAL immediately during the surgery and discard any unused contents.

Connection instructions

  1. Open the blister and make the VISTASEAL Dual Applicator and two additional Airless Spray Tips available to a second person for transfer to the sterile field. The outside of the blister should not come in contact with the sterile field.
  2. Hold the VISTASEAL syringe holder with syringe luer caps pointed upward. See Figure 3.
  3. Unscrew and discard the syringe luer cap of both fibrinogen and thrombin syringes. See Figure 3.
    Figure 3


    Figure 3

  4. Hold the syringe holder with the luers pointed upward. To remove air bubbles from syringes, strike gently the side of the syringe holder one or two times while keeping the syringe holder in an upright position and lightly depress the plunger to eject air. See Figure 4.
    Figure 4


    Figure 4

  5. Attach the Dual Applicator. See Figure 5.
    NOTE: Do not depress plunger during attachment or prior to intended use because the two biologic components will pre-mix in the Airless Spray Tip, forming a fibrin clot that prevents dispensing. See Figure 6.
    Figure 5


    Figure 5
    Figure 6


    Figure 6

  6. Tighten luer locks and ensure the Dual Applicator is firmly attached. The device is now ready to use.

Administration

For topical use only.

Apply VISTASEAL using the syringe holder and plunger supplied.

Apply VISTASEAL using the Dual Applicator provided with the product. Applicator tips cleared by the FDA for specific use with the VISTASEAL may also be used. When using the provided Dual Applicator, follow the connection instructions in the above section for Preparation. When using other applicator tips, follow the instructions for use that are provided with the applicator tips.

Before administration of VISTASEAL:

- To prevent tissue adhesion at undesired sites, protect (cover) parts of the body outside the intended application area.
- Use standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices) to dry the surface area of the target bleeding site.

Application by spraying

  1. Grasp and bend the Dual Applicator to the desired position. Tip will retain its shape.
  2. Position the Airless Spray Tip at least 2 cm away from the target tissue. Apply firm even pressure to the plunger to spray the fibrin sealant. Increase distance accordingly to achieve desired coverage of the target area.
  3. If expression is stopped for any reason, change the Airless Spray Tip prior to resuming application since a clot may form inside the Airless Spray Tip. To change the Airless Spray Tip, remove the device from the patient and unscrew the used Airless Spray Tip. See Figure 7. Place the used Airless Spray Tip away from the spare Airless Spray Tips. Wipe the end of the applicator using dry or moist sterile surgical gauze. Then, connect a new Airless Spray Tip provided in the package and ensure it is firmly connected before use.
    NOTE: Red indicator will not be visible if Airless Spray Tip is properly connected. See Figure 8.
    NOTE: Do not continue pushing the plunger in an attempt to clear the fibrin clot within the Airless Spray Tip; otherwise the applicator may become unusable.
    NOTE: Do not trim the Dual Applicator to avoid exposing internal wire.
    Figure 7


    Figure 7

    Figure 8


    Figure 8

Application by dripping

  1. Remove the Airless Spray Tip portion of the spray and drip tip by unscrewing the Airless Spray Tip.
    See Figure 7.
  2. Grasp and bend the drip tip to the desired position. Tip will retain its shape.
  3. During dripping, keep the end of the drip tip as close to the tissue surface as possible without touching the tissue during application.
  4. Apply individual drops to the surface area to be treated. To prevent uncontrolled clotting, allow the drops to separate from each other and from the end of the drip tip.
    NOTE: Do not reconnect a used drip tip after it has been removed from the adapter; otherwise a clot may form inside the drip tip and the applicator may become unusable.

Application precautions

  • Before administration of VISTASEAL, protect (cover) parts of the body outside the desired application area to prevent tissue adhesion at undesired sites.
  • Apply VISTASEAL as a thin layer. Excessive clot thickness may negatively interfere with the product’s efficacy and the wound healing process.
  • Only spray VISTASEAL if it is possible to accurately judge the distance from the spray tip to the tissue surface.
  • No clinical data are available to support the use of this product in neurosurgery or application through a flexible endoscope for treatment of bleeding.

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