Optimum Use Conditions; Contraindication; Warnings - KCI Prevena Intrucciones De Uso

OPTIMUM USE CONDITIONS

For maximum benefit the PREVENA™ Incision Management 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™ Incision Management System will not be effective in addressing complications
associated with:
•
ischemia to the incision or incision area
•
untreated or inadequately treated infection
•
inadequate hemostasis of the incision
•
cellulitis of the incision area
The PREVENA™ Incision Management 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.
Consider using the smallest available canister for the selected V.A.C.® Therapy Unit.
The PREVENA™ Incision Management 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™ Incision Management 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™ Incision Management 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, PREVENA™ Therapy should be
discontinued until the infection is treated.
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