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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.
Contraindications
- 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.
