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complications. Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased
warmth in the wound or periwound area, purulent discharge, or strong odor. Infection can be serious,
and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or
fatal injury. Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache,
dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory
and/or orthostatic hypotension, or erythroderma (a sunburn-like rash). If there are any signs of the onset of
systemic infection or advancing infection at the wound site, contact a physician immediately to determine if
V.A.C.
®
Therapy should be discontinued. For wound infections relating to blood vessels, please also refer to
the section titled Infected Blood Vessels.
Osteomyelitis:
The V.A.C.
®
System should NOT be initiated on a wound with untreated osteomyelitis.
Consideration should be given to thorough debridement of all necrotic, non-viable tissue, including infected
bone (if necessary), and appropriate antibiotic therapy.
Protect Tendons, Ligaments and Nerves:
Tendons, ligaments and nerves should be protected to avoid
direct contact with V.A.C.
®
Foam Dressings. These structures may be covered with natural tissue, meshed
non-adherent material, or bio-engineered tissue to help minimize risk of desiccation or injury.
Foam Placement:
Always use V.A.C.
®
Dressings from sterile packages that have not been opened or
damaged. Do not place any foam dressing into blind/unexplored tunnels. The V.A.C.
®
WhiteFoam Dressing
may be more appropriate for use with explored tunnels. Do not force foam dressings into any area of the
wound, as this may damage tissue, alter the delivery of negative pressure, or hinder exudate and foam
removal. Always count the total number of pieces of foam used in the wound and document that number
on the foam quantity label and in the patient’s chart. Document the dressing change date on the foam
quantity label.
Foam Removal:
V.A.C.
®
Foam Dressings are not bioabsorbable. Always count the total number of foam
pieces removed from the wound and ensure the same number of foam pieces was removed as was placed.
Foam left in the wound for greater than the recommended time period may foster ingrowth of tissue
into the foam, create difficulty in removing foam from the wound, or lead to infection or other adverse
events. If significant bleeding develops, immediately discontinue the use of the V.A.C.
®
Therapy System,
take measures to stop the bleeding, and do not remove the foam dressing until the treating physician or
surgeon is consulted. Do not resume the use of the V.A.C.
®
Therapy System until adequate hemostasis has
been achieved, and the patient is not at risk for continued bleeding.
Keep V.A.C.
®
Therapy On:
Never leave a V.A.C.
®
Dressing in place without active V.A.C.
®
Therapy for
more than two hours. If therapy is off for more than two hours, remove the old dressing and irrigate the
wound. Either apply a new V.A.C.
®
Dressing from an unopened sterile package and restart V.A.C.
®
Therapy;
or apply an alternative dressing at the direction of the treating clinician.
Acrylic Adhesive:
The V.A.C.
®
Advanced Drape has an acrylic adhesive coating, which may present a risk
of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives. If a patient has a
known allergy or hypersensitivity to such adhesives, do not use the V.A.C.
®
Therapy System. If any signs of
allergic reaction or hypersensitivity develop, such as redness, swelling, rash, urticaria, or significant pruritus,
discontinue use and consult a physician immediately. If bronchospasm or more serious signs of allergic
reaction appear, seek immediate medical assistance.
Defibrillation:
Remove the V.A.C.
®
Dressing if defibrillation is required in the area of dressing placement.
Failure to remove the dressing may inhibit transmission of electrical energy and/or patient resuscitation.
Magnetic Resonance Imaging (MRI) -Therapy Unit:
The V.A.C.
®
Therapy Unit is MR Unsafe. Do not
take the V.A.C.Via
™
Unit into the MR environment.
Magnetic Resonance Imaging (MRI) -V.A.C.
®
Dressings:
V.A.C.
®
Dressings can typically remain on
the patient with minimal risk in an MR environment, assuming that use of the V.A.C.
®
Therapy System is not
interrupted for more than two hours (refer to Keep V.A.C.
®
Therapy On above).
Hyperbaric Oxygen Therapy (HBO):
Do not take the V.A.C.
®
Therapy Unit into a hyperbaric oxygen
chamber. V.A.C.
®
Therapy Unit are not designed for this environment, and should be considered a fire
hazard. After disconnecting the V.A.C.
®
Therapy Unit, either (i) replace the V.A.C.
®
Dressing with another
HBO compatible material during the hyperbaric treatment, or (ii) cover the unclamped end of the V.A.C.
®
Tubing with moist cotton gauze. For HBO therapy, the V.A.C.
®
Tubing must not be clamped. Never leave a
V.A.C.
®
Dressing in place without active V.A.C.
®
Therapy for more than two hours; please refer to the Keep
V.A.C.
®
Therapy On section above.
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