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.
Caution should be used in treating patients on doses of anticoagulants or platelet aggregation inhibitors
thought to increase their risk for bleeding (relative to the type and complexity of the wound). Consideration
should be given to the negative pressure setting and therapy mode used when initiating therapy.
Hemostatic agents applied at the wound site: Non-sutured hemostatic agents (for example, bone wax, absorb-
able 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 causing injury.
Any injury could cause bleeding, which, if uncontrolled, could be potentially fatal. Beware of possible shifting in the
relative position of tissues, vessels or organs within the wound that might increase the possibility of contact with
sharp edges. Sharp edges or bone fragments must be eliminated from the wound area or covered to prevent them
from puncturing blood vessels or organs before the application of therapy. Where possible, completely smooth and
cover any residual edges to decrease the risk of serious or fatal injury, should shifting of structures occurs.
Use caution when removing dressing components from the wound so that wound tissue is not damaged by unpro-
tected sharp edges.
Infected wounds: Infected wounds should be monitored closely and may require more frequent dressing changes
than non-infected wounds, dependent upon factors such as wound conditions and treatment goals. Refer to dress-
ing application instructions for details regarding dressing change frequency. As with any wound treatment, clinicians
and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of
infection, worsening infection, or other complications. Some signs of infection are fever, tenderness, redness, swell-
ing, 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, diz-
ziness, 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 therapy should be discontinued.
Osteomyelitis: The therapy system should NOT be initiated on a wound with untreated osteomyelitis. Consideration
should be given to thorough debridement of all necrotic, nonviable 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 con-
tact with gauze dressings. These structures may be covered with natural tissue, meshed non-adherent material, or
bioengineered tissue to help minimize risk of desiccation or injury.
Gauze placement: Always use dressings from sterile packages that have not been opened or damaged. Do not
place any gauze dressing pieces into blind/unexplored tunnels. Do not force gauze dressings into any area of the
wound, as this may damage tissue, alter the delivery of negative pressure, or hinder exudate and gauze removal.
Always count the total number of pieces of gauze used in the wound and document that number on the Transparent
Film and in the patient's chart. Also document the dressing change date on the Transparent Film.
Gauze removal: gauze dressings are not bioabsorbable. Always count the total number of pieces of gauze
removed from the wound and ensure the same number of gauze pieces was removed as placed. Gauze left in
the wound for greater than the recommended time period may foster ingrowth of tissue into the gauze, create diffi-
culty in removing gauze from the wound, or lead to infection or other adverse events. Regardless of treatment modal-
ity, disruption of new granulation tissue during any dressing change may result in bleeding at the wound site. Minor
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