Procellera™ Composite Antibacterial Wound Dressing is a 3-layer dressing, comprising a broad-spectrum antibacterial contact layer, a polyester-based absorbent layer and a polyurethane semi-occlusive outer adhesive layer to keep the dressing in place and help maintain a moist wound environment.
Procellera™ Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for partial- and full-thickness wounds such as pressure injuries, venous ulcers, diabetic ulcers, first- and second degree burns, surgical incisions, donor and recipient graft sites, etc.
Do not use on individuals with sensitivity or allergy to silver, zinc, or other dressing components.
• Frequent or prolonged use of this product may result, in rare occasions, in temporary discoloration of the skin.
• Caution: Federal law restricts this device to sale by or on the order of a physician.
• Single use only.
• For external use only.
• Gamma irradiation sterilized. Opening the dressing pack compromises the sterile barrier. Do not use if the pouch is open or damaged prior to use.
• Do not apply Procellera™ Composite in conjunction with topical agents such as antimicrobial ointments, enzymatic debriders, antibiotic creams or ointments, silver- or zinc-containing creams, oxidizing agents, or petroleum-based products.
• The use of adhesive dressings on fragile or sensitive skin may pose a risk of skin damage upon removal of the dressing. To mitigate this risk, a skin prep may be applied on the wound perimeter prior to dressing application (not included).
• The patient should stop using the dressing and consult a physician if allergy, irritation, increased pain, maceration, or any irregular skin discoloration occurs.
• Procellera™ Composite is not intended to be used on wounds with uncontrolled bleeding.
• Remove Procellera™ Composite during energy-based procedures (such as radiofrequency, ultrasound, or radiation) where the dressing may interfere with delivery.
• MR unsafe. Remove Procellera™ Composite prior to a MRI or HBOT procedure and apply a new dressing after the procedure.
• Avoid direct dressing contact with electrodes or conductive gels during electronic measurements; eg, EEG or ECG.
• Procellera™ Composite may be used on infected wounds being clinically managed, as an adjunct to the local clinical protocol.
• The safety of daily Procellera™ Composite use for longer than 28 days has not been studied.
The patient should consult a physician if any of the following occur: infection, bleeding, maceration, hypergranulation, irritation at the wound and/or the surrounding skin, or if the wound increases in size.
Non/Minimally Exudating Wounds
1. Cleanse wound area with an appropriate wound cleanser according to local clinical protocol.
2. Peel back center liner to expose the dotted Procellera™ pad, leaving edge liners in place. Moisten the dotted Procellera™ pad with sterile saline, water, or a thin, even layer of hydrogel (not included).
3. Position the dotted Procellera™ pad over wound and gently press down to ensure direct contact. Note: If dressing a joint, apply dressing while joint is in slight flexion.
4. Remove remaining liners and smooth adhesive down over skin.
Procellera™ Composite may be left in place for up to 7 days. Earlier and/or more frequent changes may be required, depending on the amount of exudate present and the condition of the wound and/or the surrounding skin. Inspect the wound site periodically. To remove Procellera™ Composite, lift one corner and gently pull back in the direction of the wound. If it adheres to the wound surface, do not force it off; moisten or soak the dressing with sterile saline or water until it can be removed without tissue disruption.
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