Frequently Asked Questions
|What is Procellera?||Procellera is an antimicrobial wound device. It is a primary contact layer, non-adhesive dressing.|
|Does Procellera have FDA clearance?||Yes.|
|Can Procellera be used on chronic wounds?||Yes, including: pressure ulcers, venous ulcers, diabetic ulcers, etc.|
|Can Procellera be used on acute wounds?||Yes, including: minor wounds, surgical incisions, burns, donor and recipient graft sites, etc.|
|What is unique about Procellera?||Procellera is bioelectric by inherent design: in the presence of a conductive fluid, microcurrents occur over the entire device surface.|
|Does Procellera have any accessories?||No, there are no accessories. Procellera is self-contained and has no electrical wires.|
|What is the device made of?||The main components of the device are polyester, silver and zinc.|
|What are the dots on Procellera?||The dots are natural elements; when wet, they function as microbatteries that generate electrical currents on the device surface. The large dots contain elemental silver and the small dots contain elemental zinc.|
|Which side should be applied on the wound?||The dotted side is the correct application side. Note that when wet, this might be less obvious; identify the correct application side before wetting the dressing.|
|Does it work upside down?||No, the dotted side must be applied in direct contact with the wound surface.|
|Can I cut Procellera?||Yes, it may be cut to size. Extend beyond the wound perimeter onto healthy skin area by approximately 1-2 cm (1/2 – 1 inch). Sharp scissors are recommended to minimize fraying of the woven polyester.|
|Can I cut through a dot?||Yes, it will not affect the device.|
|Can I cut slits in it?||Yes. Some devices already have slits / fenestrations, but more may be added if needed to facilitate transfer of fluids to and from the wound.|
|What if there is a variation in the color of the dots?||The variation in the color of the dots on a new dressing is normal and does not affect the device performance.|
|Why does Procellera need to be moistened?||The currents occur only in the presence of a conductive fluid. For optimal results, keep Procellera moist.|
|How much voltage does it produce?||Voltage potential in the range of 0.3 to 0.9 Volts has been measured.|
|How much current does it produce?||In the presence of a conductive fluid and across a nominal tissue load, current in the order of 10 micro Amperes has been measured.|
|Can the current be felt?||No, it is many times below the threshold of sensation.|
|What happens if Procellera becomes dry on the wound?||It still provides an antimicrobial barrier to the wound; however, no current is present.|
|APPLICATION, MOISTENING & SECONDARY DRESSINGS|
|What wound cleansing agents are appropriate?||The choice of wound cleanser is at the discretion of the treating clinician. However, if using a cleanser other than sterile water or sterile saline, we recommend rinsing off residuals before applying Procellera.|
|What moistening agents are appropriate?||Conductive fluids such as sterile water, sterile saline, water-based hydrogels, or wound exudate.|
|How wet does it need to be?||Before applying, saturate the dressing and allow the moistening fluid to be absorbed. Remove excess moisture and apply. After application, check the dressing periodically and remoisten if necessary, by adding a sterile moistening fluid.|
|Why is a secondary dressing or a bandage needed?||A secondary dressing or a bandage is needed to keep Procellera in place and to help maintain a moist wound environment at the wound site.|
|What kind of secondary dressings are recommended?||Any sterile semi-occlusive dressing such as Tegaderm, Op-site, waterproof dressings, etc. However, silver-containing dressings are not recommended, in an effort to prevent argyria.|
|What secondary dressings are recommended in case of adhesive sensitivity?||Specialized adhesives may be used for those with sensitive skin, such as silicone adhesives or self-adherent circumferential wrap|
|What if the wound is dry?||To provide prolonged moisture to the wound site, use hydrogel as moistening agent and /or apply layer(s) of saline-moistened gauze over Procellera, then secure in place.|
|What if there is excess exudate?||To absorb excessive moisture and prevent maceration, cover Procellera with absorptive dressing such as layers of sterile gauze or foam dressing. Protecting the peri-wound and more frequent changes of the secondary dressing may also be needed.|
|Can Procellera be used on an infected wound?||Yes, 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.|
|Can Procellera be used in a cavity or tunneled wound?||Yes. Line Procellera over the base of the cavity and “bolster” it in place with gauze pads; cover with an appropriate secondary dressing / fixation.
It is not recommended to use trimmed pieces of Procellera on tunneled wounds, since loose threads of fabric may become “hidden” in the wound bed.
|How long may Procellera be left in place?||Procellera may be left in place for up to 7 days. Prolonged application is at the discretion of the treating clinician.|
|How often should the Procellera dressing be changed?||At least once a week, providing that no complications occur. Earlier or more frequent changes may be necessary (e.g., 2-3 times a week), depending on the amount of exudate and bacterial load.|
|What happens if the dots fade during wear?||It is natural for the dots to gradually fade with wear, especially in the presence of excessive exudate. However, it is recommended to change the dressing if the dots begin to disappear.|
|How often should the secondary dressing(s) be changed?||It is recommended to change the secondary dressing(s) when it becomes soiled or when removing it to re-moisten Procellera.|
|What should be expected at dressing change?||Improved wound bed appearance is normally expected.
However, in some cases, the appearance of the dressing(s) can be deceptive. Mucoid material and staining on the dressing(s) may be present, and there may be some unpleasant odor associated. While this may be interpreted as increasing colonization or infection, this however is usually normal and should disappear after removing the soiled dressings and mild cleansing of the wound.
|Increased exudate and / or odor were noted at dressing change – is this normal?||Increased exudate, staining of the dressing(s) and odor may be noted with certain wound types, especially with longer intervals between dressing changes.
While this may be interpreted as increasing colonization or infection, this however is usually normal and should disappear after removing the soiled dressings and mild cleansing of the wound. Carefully inspect the wound for objective signs of healing.
Tips for odor and exudate control include increased frequency of dressing changes and addition of absorptive layers over Procellera.
|Can Procellera be used with Negative Pressure Wound Therapy?||Yes, Procellera may be used as an interface dressing under NPWT. Positive outcomes have been reported when using Procellera as an adjunct to NPWT.|
|Can Procellera be used with pressure casting?||Yes. Positive outcomes have been reported when using Procellera as an adjunct to pressure casting.|
|Can Procellera be used with HBOT (Hyperbaric Oxygen Therapy)?||Yes. Positive outcomes have been reported when using Procellera as an adjunct to HBOT.|
|Does Procellera need to be removed prior to HBOT?||It is recommended to remove Procellera prior to HBOT procedure and to apply a new dressing after the procedure. The interaction of Procellera with the HBOT equipment has not been studied. Consult the HBOT provider for clarification.|
|Does Procellera need to be removed prior to MRI?||Yes, remove the dressing prior to any MRI examination.|
|Does Procellera need to be removed prior to electronic measurements (e.g. EEG or ECG)?||Yes, only if the dressing is applied where the electrodes will be placed. Avoid contact with electrodes or conductive gels during any electronic measurements.|
|Does Procellera need to be removed prior to energy-based treatments or procedure (such as ultrasound, radiation, radiofrequencies, and any other energy delivery procedures)?||Yes, only if the dressing may interfere with the delivery method. Specifically, if the dressing is applied on the area where the procedure / treatment is planned, or if the equipment may interact with the dressing components, then remove the dressing prior to procedure / treatment. Consult the procedure provider for clarification.|
|Can patients with pacemakers or AICD use Procellera dressings?||Yes. However, if the wound is next to or over the pacemaker / AICD, consult a physician. The interaction of Procellera micro-current with pacemakers and AICD has not been studied.|
|Can Procellera be used with topical agents (such as antimicrobial ointments, enzymatic debriders, antibiotic creams, silver or zinc containing creams, oxidizing agents, petroleum based products, etc)?||No. Do not use Procellera with topical agents since they may interact with its components or may interfere with its electrical properties. These agents must be rinsed off the wound with an appropriate cleanser prior to application of Procellera.|
|How can a physician / hospital purchase Procellera?||Call 480-921-4948 or fax the order to 480-921-0948.|
|Is Procellera reimbursed?||Yes- as contact layer dressings (A6206 - A6208)|
|Is training available?||Yes, we provide training to clinicians and medical facilities. To schedule training or in-service, contact us at 480-921-4948|
|Is a prescription needed in order to purchase Procellera?||Yes, Procellera is a prescription device and can be sold only by or on the order of a licensed healthcare practitioner.|
|How can a patient purchase Procellera?||Patients should order through a physician or mail us an original prescription.|