Evarrest Dosage

Preparation

• EVARREST® comes ready to use in sterile packages and must be handled using sterile technique in aseptic conditions. Discard damaged packages as resterilization is not possible.
• To open the product, remove the foil pouch from the carton, carefully peel open the foil pouch, avoiding contact with the inside of the foil or the white sterile tray containing EVARREST.
• Remove the white sterile tray from the pouch and place onto the sterile field.
• Hold the tray securely in the palm of the hand, ensuring that the side with the holes is facing upwards, and use the tabs on the side of the tray to remove the top of the tray with the other hand.
• The lower portion of the tray contains EVARREST with the active side facing downwards. The active side is powdery in appearance. The non-active side has an embossed wave pattern.
• Keep EVARREST dry after opening. The patch can remain in the sterile field to be available for use throughout the procedure. EVARREST does not stick to gloves, forceps, or surgical instruments.

Application

Apply topically to the bleeding site only.

1. Using sterile scissors, carefully cut the patch to the size and shape as necessary to fit and maintain contact with the bleeding area with an overlap of approximately 0.5 to 1 inch (1 to 2 cm). Keep the powdery white-to-yellow color active side of the patch facing down while in the tray.

   

2. Remove excess blood or fluid from the site of application to improve visibility. Do not use on non-visualized surfaces. Do not use to treat bleeding from defects in large arteries or veins where the injured vascular wall requires conventional surgical repair for maintenance of vessel patency.
3. Apply the active side of the patch to the bleeding area. Allow full contact with the tissue or prosthetic graft. The product is activated upon contact with fluid and then adheres, conforming to tissue with continuous manual compression.

   

4. Apply a sufficient number of patches to adequately cover the entire bleeding area, with an overlap of approximately 0.5 to 1 inch (1 to 2 cm). Use the least number of patches to cover the bleeding area [see Warnings and Precautions (5.6)].

   

5. (a) Hold dry or moist laparotomy pads or surgical gauze over EVARREST® to achieve full contact with the bleeding surface.

   

   
   (b) To ensure hemostasis, immediately apply continuous manual compression over the entire surface of the patch (including the area of overlap) sufficient to stem all bleeding. Ensure even pressure distribution, full tissue apposition and avoid movement of the patch over the entire bleeding area. Maintain continuous manual compression for 3 minutes.

   

6. Gently remove laparotomy pads or surgical gauze from the application site without disrupting or dislodging EVARREST or the clot. If irrigation is necessary, use care not to dislodge the patch. Inspect the patch to ensure that it is in full contact with the treated area. If placement of the patch is unsatisfactory, remove the patch and use a new patch [see Dosage and Administration (2)]. Removal of the patch may disrupt the clot and result in re-bleeding.

   

7. Discard unused, opened patches at the end of the procedure.

Retreatment

• Retreatment may be required if there are folds, creases, or crimps in the patch. If not satisfied with the placement of the patch, or if bleeding still occurs during or after the specified duration of compression, remove the used patch and repeat the application procedure above with a new patch.
• If continued bleeding is due to insufficient coverage of the bleeding area, additional patches may be applied. Ensure that the edges overlap (by approximately 0.5 to 1 inch or 1 to 2 cm) with the existing patch.
• If continued bleeding is due to incomplete adherence to the tissue (where bleeding persists from under the dressing), remove the patch and use a new one.