CONTRAINDICATIONS
•
Do not place foam dressings of the V.A.C.® Therapy System directly in contact with exposed
blood vessels, anastomotic sites, organs or nerves.
NOTE: Refer to Warnings section for additional information concerning Bleeding.
•
V.A.C.® Therapy is contraindicated for patients with:
•
Malignancy in the wound
•
Untreated osteomyelitis
NOTE: Refer to Warnings section for Osteomyelitis information.
•
Non-enteric and unexplored fistulas
•
Necrotic tissue with eschar present
NOTE: After debridement of necrotic tissue and complete removal of eschar, V.A.C.® Therapy may be
used.
WARNINGS
Bleeding: With or without using V.A.C.® Therapy, certain patients are at high risk of bleeding
complications. The following types of patients are at increased risk of bleeding, which, if uncontrolled,
could be potentially fatal:
•
Patients who have weakened or friable blood vessels or organs in or around the wound as a
result of, but not limited to:
•
Suturing of the blood vessel (native anastamoses or grafts) / organ
•
Infection
•
Trauma
•
Radiation
•
Patients without adequate wound hemostasis
•
Patients who have been administered anticoagulants or platelet aggregation inhibitors
•
Patients who do not have adequate tissue coverage over vascular structures
If V.A.C.® Therapy is prescribed for patients who have an increased risk of bleeding
complications, they should be treated and monitored in a care setting deemed
appropriate by the treating physician.
If active bleeding develops suddenly or in large amounts during V.A.C.® Therapy, or
if frank (bright red) blood is seen in the tubing or in the canister, immediately stop
V.A.C.® Therapy, leave dressing in place, take measures to stop the bleeding and seek
immediate medical assistance. The V.A.C.® Therapy Units and dressings should not be
used to prevent, minimize or stop vascular bleeding.
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