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Indications for Use / Contraindications

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Instructions for Use

Indication for Use

  • INTEGRA™ Meshed Bilayer Wound Matrix is indicated for the management of wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. INTEGRA™ Meshed Bilayer Wound Matrix may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.


  • This device should not be used in patients with known sensitivity to bovine collagen or
    chondroitin materials
  • The device is not indicated for use in third-degree burns

When used with Negative Pressure Wound Therapy, follow Contraindications for the specific Negative Pressure Wound Therapy device utilized, such as in the presence of:

  • Exposed arteries, veins, organs, anastomotic sites or nerves
  • Malignancy in the wound
  • Untreated osteomyelitis
  • Untreated malnutrition
  • Necrotic tissue (with or without eschar present)
  • Non-enteric and unexplored fistulas
  • Sensitivity to silver (if silver dressings are used)

Warnings and Precautions

  • Do not resterilize. Discard all opened and unused portions of INTEGRA™ Meshed Bilayer
    Wound Matrix.
  • Device is sterile if the package is unopened and undamaged. Do not use if the package
    seal is broken.
  • Discard device if mishandling has caused possible damage or contamination
  • INTEGRA™ Meshed Bilayer Wound Matrix should not be applied until excessive exudate,
    bleeding, acute swelling and infection are controlled
  • Debridement or excision must be done thoroughly to remove any remaining necrotic tissue
    that may cause infection
  • Do not stretch, expand, spread or remesh the device
  • The following complications are possible with the use of wound dressings. If any of these
    conditions occur, the device should be removed: infection, chronic inflammation (initial
    application of wound dressings may be associated with transient, mild, localized inflammation), allergic reaction, excessive redness, pain or swelling.

When used with Negative Pressure Wound Therapy, follow Warnings and Precautions for
the specific Negative Pressure Wound Therapy device utilized, such as:

  • Precautions for patients who are or may be receiving anticoagulant therapy
    or suffering from difficult hemostasis
  • Excessive bleeding is a serious risk associated with the application of suction to
    wounds and may result in death or serious injury. Careful patient selection, in view
    of the above-stated contraindications, warnings and precautions, is essential. Carefully
    monitor the wound and collection circuit for any evidence of a change in the blood
    loss status of the patient. Notify the Physician of any sudden or abrupt changes
    in the volume or the color of exudate.

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