INSTRUCTIONS FOR USE
For full prescribing information, download Instructions for Prescription Use
Instructions for Prescription Use (PDF)
INSTRUCTIONS FOR APPLICATION
Note that local hygiene procedures should be followed prior to and following dressing application and changes.
1. Cleanse the wound area with appropriate wound cleanser.
2. Remove Procellera from package and if needed, cut it to a shape that will extend beyond wound edges 1 to 2 cm (½ inch to 1 inch).
3. Moisten Procellera with a sterile agent such as saline solution, water, or water-based wound gel (hydrogel).
4. Apply Procellera dressing to the wound site, with the dotted side against and directly contacting the wound surface.
5. Cover Procellera with an appropriate secondary sterile dressing which will maintain a moist wound environment. The choice of secondary dressing should be determined by the degree of exudate produced by the wound:
➢ For DRY wounds: waterproof, semi-permeable or hydrogel-like dressings are recommended, to ensure prolonged moisture.
➢ For EXUDATING wounds: cover Procellera with layer(s) of sterile gauze or foam dressing, to absorb excessive moisture and to prevent maceration.
If needed, secure in place with additional fixation dressing, using care not to restrict blood flow.
6. Keep the dressing moist by re-moistening as necessary. Avoid over-soaking.
➢ DRY wounds may require more frequent re-moistening of the dressing(s).
➢ EXUDATING wounds require dressing re-moistening only if exudate decreases and the dressing becomes dry.
SITE CARE AND DRESSING CHANGES
• Inspect the wound site periodically.
• To remove the dressing, gently pull it back. If the dressing adheres to the wound surface, do not force it off; moisten or soak it with sterile saline or sterile water until it can be removed without tissue damage.
• Procellera may be left in place for up to 7 days. Earlier and /or more frequent changes might be required, depending on the amount of exudate present and the condition of the wound and the surrounding skin.
• A physician should be consulted if any of the following occur:
- Infection;
- Bleeding;
- Maceration (skin whitening and softening);
- Hypergranulation (excessive tissue formation);
- Any irritation at the wound site or in the skin surrounding the dressing;
- Wound increases in size after a few dressing changes.
WARNINGS
Frequent or prolonged use of silver may result in permanent discoloration of skin and mucous membranes
(e.g., argyria).
CONTRAINDICATIONS
• Procellera should not be used on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.
• Do not use on patients with a known sensitivity to silver or zinc.
• Do not use on patients during MRI (Magnetic Resonance Imaging) examination.
• Do not use on wounds with uncontrolled bleeding.
PRECAUTIONS
• Procellera should be used under the supervision of a qualified health care professional.
• The safety of using Procellera daily for longer than 28 days has not been studied.
• For external use only. Single use only.
• Do not use if the pouch is open or damaged prior to use.
• Procellera may be used on infected wounds that are being managed in accordance with institutional clinical protocols for infection abatement as an adjunct to the standard treatment regimen.
• Avoid contact with electrodes or conductive gels during electronic measurements; e.g., EEG or ECG.
• Do not use Procellera during energy-based procedures or delivery systems (such as electricity, radiofrequencies, ultrasound, radiation, etc.) where the dressing may interfere with delivery.
• Do not use Procellera with topical agents such as antimicrobial ointments, enzymatic debriders, antibiotic creams, silver or zinc containing creams, oxidizing agents, petroleum based products, etc.
• 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 or any irregular skin discoloration occur.