Optimum Use Conditions; Contraindication; Warnings - Acelity PREVENA INCISION Manual De Uso

OPTIMUM USE CONDITIONS

For maximum benefit the PREVENA™ Therapy System should be applied immediately post
surgery to clean surgically closed wounds. It is to be continuously applied for a minimum of two
days up to a maximum of seven days. It can transition home with the patient.
The PREVENA™ Therapy System will not be effective in addressing complications associated with
the following:
ischemia to the incision or incision area
•
untreated or inadequately treated infection
•
The PREVENA™ Therapy System should not be used to treat open or dehisced surgical wounds.
The V.A.C.® Therapy System should be considered for treatment of these wounds.
A V.A.C.® Therapy Unit with the smallest available canister should be considered for patients who
have exudate volumes that exceed the PREVENA™ 45ml Canister.
The PREVENA™ Therapy System should be used with caution in the following patients:
patients with fragile skin surrounding the incision as they may experience skin or tissue
•
damage upon removal of the PREVENA™ Dressing
patients who are at an increased risk of bleeding from the incision associated with the use
•
of anticoagulants and/or platelet aggregation inhibitors

CONTRAINDICATION

sensitivity to silver
•

WARNINGS

The PREVENA™ Therapy System is not intended to manage open or dehisced wounds.
DO NOT use with V.A.C. VERAFLO™ Therapy (Instillation) provided by the V.A.C.ULTA™
Therapy Unit. Instillation into the incision site may result in pooling of fluid which may result in
maceration.
Bleeding: Before applying the PREVENA™ Therapy System to patients who are at risk of bleeding
complications due to the operative procedure or concomitant therapies and/or co-morbidities,
ensure that hemostasis has been achieved and all tissue planes have been approximated. If
active bleeding develops suddenly or in large amounts during therapy, or if frank blood is seen
in the tubing or in the canister, the patient should leave the PREVENA™ Dressing in place, turn
off the therapy unit and seek immediate emergency medical assistance.
Infected Wounds: As with any wound treatment, clinicians and patients/caregivers should
frequently monitor the patient's wound, periwound tissue and exudate for signs of 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). Silver in the interface layer of the PREVENA™ Dressing is
not intended to treat infection, but to reduce bacterial colonization in the fabric. If infection
develops, the PREVENA™ Therapy System should be discontinued until the infection is
treated.
inadequate hemostasis of the incision
•
cellulitis of the incision area
•
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