Procellera™ Single Layer Antimicrobial Wound Dressing is a broad-spectrum antimicrobial single layer to be used under a secondary dressing (not included) to keep the dressing in place and help maintain a moist wound environment.
Procellera™ Single Layer Antimicrobial 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.
• Electron beam 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™ Single Layer 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.
• Secondary dressings should be used as stated in their instructions for use.
• The patient should stop using the dressing and consult a physician if allergy, irritation, increased pain, maceration, or any irregular skin discoloration occurs.
• Procellera™ Single Layer is not intended to be used on wounds with uncontrolled bleeding.
• Remove Procellera™ Single Layer during energy-based procedures (such as radiofrequency, ultrasound, or radiation) where the dressing may interfere with delivery.
• MR unsafe. Remove Procellera™ Single Layer 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™ Single Layer may be used on infected wounds being clinically managed, as an adjunct to the local clinical protocol.
• The safety of daily Procellera™ Single Layer use for longer than 28 days has not been studied.
• The dressing has been used safely directly over sutures, wound closure strips, staples and liquid skin adhesives and with bioengineered skin substitutes, negative pressure wound therapy, and multilayer compression therapy.
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.
V.Dox™ Technology
Acute Wounds
Burns
Cavity Wounds
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Infected Wounds
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Pressure Ulcers
Sloughy Wounds
Superficial Wounds
Surgical Wounds
Traumatic Wounds
Venous Ulcers
1. Cleanse wound area with an appropriate wound cleanser according to local clinical protocol. Note: If needed, cut Procellera™ Single Layer to a shape that will extend 1cm to 2cm beyond wound edges (cutting may result in fraying of the dressing).
2. Moisten Procellera™ Single Layer with sterile saline, water or a thin, even layer of hydrogel (not included).
3. Apply Procellera™ Single Layer with the dotted side down in direct contact with the wound.
4. Cover Procellera™ Single Layer with an appropriate sterile secondary dressing to help maintain a moist wound environment and secure in place. Note: Keep Procellera™ moist by re-moistening as necessary.
• Procellera™ Single Layer 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™ Single Layer, gently pull back. 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.
Cover Procellera™ Single Layer with an appropriate sterile secondary dressing to help maintain a moist wound environment and secure in place.
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