– If active bleeding develops suddenly or in large amounts during therapy, or if frank
(bright red) blood is seen in the tubing or in the canister, immediately stop therapy,
leave dressing in place, take measures to stop the bleeding and seek immediate med-
ical assistance.
– The therapy units and dressings should not be used to prevent, minimize or stop
vascular bleeding.
– Do not resume the use of the therapy system until adequate hemostasis has been
achieved and the patient is not at risk of continued bleeding.
Protect vessels and organs:
– All exposed or superficial vessels and organs in the abdominal wound must be completely
covered and protected prior to the administration of therapy. Always ensure that foam
dressings do not come in direct contact with vessels or organs.
Infected blood vessels:
– Infection may erode blood vessels and weaken the vascular wall which may increase sus-
ceptibility to vessel damage through abrasion or manipulation. Infected blood vessels are
at risk of complications, including bleeding, which, if uncontrolled, could be poten-
tially fatal. Extreme caution should be used when therapy is applied in close proximity
to infected or potentially infected blood vessels.
Hemostasis, anticoagulants and platelet aggregation inhibitors:
– Patients without adequate wound hemostasis have an increased risk of bleeding, which, if
uncontrolled, could be potentially fatal. These patients should be treated and monitored in a
care setting deemed appropriate by the treating physician.
Hemostatic agents applied at the wound site:
– Non-sutured hemostatic agents (for example, bone wax, absorbable gelatin sponge, or
spray wound sealant) may, if disrupted, increase the risk of bleeding, which, if uncontrolled,
could be potentially fatal. Protect against dislodging such agents. Consideration should be
given to the negative pressure setting and therapy mode used when initiating therapy.
Sharp edges:
– Bone fragments or sharp edges could puncture protective barriers, vessels, or organs caus-
ing injury. Any injury could cause bleeding, which, if uncontrolled, could be potentially fatal.
– Sharp edges or bone fragments must be eliminated from the wound area or covered to pre-
vent them from puncturing blood vessels or organs before the application of therapy.
Infected wounds:
– Infected abdominal wounds should be monitored closely and may require more frequent
dressing changes than non-infected wounds, dependent upon factors such as wound con-
ditions and treatment goals.
– Objective indications or signs of a possible infection or complication must be addressed im-
mediately (e.g. fever, pain, redness, increased warmth, swelling or purulent discharge).
Non-observance can lead to considerable danger to the patient.
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