KCI NPWT Sicherheitshinweise, Anwendungsanweisungen Seite 4

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Infected Blood Vessels: Infection
may erode blood vessels and weaken
the vascular wall which may increase
susceptibility to vessel damage through
abrasion or manipulation. Infected blood
vessels are at risk of complications,
including bleeding, which, if
uncontrolled, could be potentially fatal.
Extreme caution should be used when
NPWT is applied in close proximity to
infected or potentially infected blood
vessels. (Refer to Protect Vessels and
Organs section above). The patient should
be closely monitored for bleeding in a
care setting deemed appropriate by the
treating physician.
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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.
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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.
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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
covered or eliminated from the wound area
to prevent them from puncturing blood
vessels or organs before the application of
NPWT. Where possible, completely smooth
and cover any residual edges to decrease
the risk of serious or fatal injury, should
shifting of structures occur. Use caution
when removing dressing components from
the wound so that wound tissue is not
damaged by unprotected sharp edges.
1000 mL Canister: DO NOT USE the 1000
mL canister on patients with a high risk of
bleeding or on patients unable to tolerate
a large loss of uid volume, including
children and the elderly. Consider the size
and weight of the patient, patient condition,
wound type, monitoring capability and care
setting when using this canister. This canister is
recommended for acute care (hospital) use only.
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 dressing 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, 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 the
treating physician immediately to determine
if NPWT should be discontinued. For wound
infections relating to blood vessels, please
also refer to the section titled Infected Blood
Vessels.
Osteomyelitis: NPWT 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 intact
bone with a single layer of non-adherent
material.
Protect Tendons, Ligaments and Nerves:
Tendons, ligaments and nerves should be
protected to avoid direct contact with KCI®
NPWT Gauze 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.
Sensitivity to PHMB: The Kerlix™ AMD™ Super
Sponges contain PHMB, which may present
a risk of an adverse reaction in patients who
are allergic or hypersensitive to PHMB. If a
patient has a known allergy or hypersensitivity
to PHMB, do not use KCI® NPWT Gauze
Dressings. If any signs of allergic reaction or
hypersensitivity develop, such as redness,
swelling, rash, urticaria or signi cant pruritus,
discontinue use and consult a physician
immediately. If bronchospasm or more
serious signs of allergic reaction appear, seek
immediate medical assistance.
Gauze Placement: Always use KCI® NPWT
Gauze Dressings from sterile packages that
have not been opened or damaged. Do not
force gauze 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. Document
the gauze quantity and dressing change date
on the drape and in the patient's chart. KCI®
NPWT Gauze dressing is radiolucent and not
detectable with X-Ray.