PuraPly® Antimicrobial Wound Matrix
PuraPly® Antimicrobial Wound Matrix is a native collagen matrix coated with polyhexamethylene biguanide hydrochloride (PHMB) intended for the management of acute and chronic wounds, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous and diabetic ulcers.
• A purified collagen matrix combined with PHMB
• Creates a durable, biocompatible scaffold and an effective barrier against a wide range of microorganisms
• Disrupts and inhibits the formation of biofilm on the wound surface
PuraPly® Antimicrobial Wound Matrix is intended for the management of wounds and as an effective barrier to resist microbial colonization within the dressing and reduce microbes penetrating through the dressing.
PuraPly® Antimicrobial Wound Matrix is indicated for the management of: partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.
This device is derived from a porcine source and should not be used in patients with known sensitivity to porcine material.
The device is not indicated for use in third-degree burns.
Do not use on individuals with a known sensitivity to polyhexamethylenebiguanide hydrochloride (PHMB)
Do not resterilize. Discard all open and unused portions of PuraPly® Antimicrobial Wound Matrix.
Device is sterile if the package is dry, unopened and undamaged. Do not use if the package seal is broken.
The device must be used prior to the expiration date.
Discard device if mishandling has caused possible damage or contamination.
PuraPly® Antimicrobial Wound Matrix should not be applied until excessive exudate, bleeding, acute infection and significant swelling are controlled.
The following complications are possible with the use of wound dressings. If any of these conditions occur, the device should be removed.
• Worsening infection
• Chronic inflammation (initial application of wound dressings may be associated with transient, mild, localized inflammation)
• Allergic reaction
• Excessive redness, pain, swelling or blistering
This device should be stored in a clean, dry location at room temperature.
|Assigned HCPCS code||●|
|Shelf life greater than 2 years||●|
|Shelf life limited|
|Indicated for acute wounds||●|
|Indicated for chronic wounds||●|
|Indicated for diabetic ulcers||●|
|Indicated for pressure ulcers||●|
|Indicated for second-degree burns|
|Indicated for surgical wounds||●|
|Indicated for third-degree burns|
|Indicated for venous ulcers||●|
|Contact manufacturer for usage guidelines|
Always handle PuraPly® Antimicrobial Wound Matrix using aseptic technique. Prepare wound area using standard methods to ensure wound is free of debris and necrotic tissue. If necessary, surgically debride the wound to ensure the wound edges contain viable tissue. To apply, cut the dry sheet to the outline of the wound area. If the wound is larger than a single sheet, then multiple sheets may be used. Overlap adjoining sheets to provide coverage of the entire wound. For ease of handling, apply PuraPly® Antimicrobial Wound
Matrix by placing in a dry state over the wound and rehydrate the sheet using sterile saline or other isotonic solution. Place the edge of the sheet in contact with the intact tissue. Smooth PuraPly® Antimicrobial Wound Matrix into place to ensure the sheet is in contact with the underlying wound bed. The sheet may be fixed to the wound using sutures or other fixation method. The optimum fixation method is determined by wound location, size, depth and user preference. Apply secondary dressings as appropriate for the type and stage of wound.
NOTE: If excess exudate collects under the sheet, small openings can be cut in the sheet to allow the exudates to drain.
IMPORTANT: After application, use an appropriate, nonadherent, secondary dressing to maintain a moist wound environment. The optimum secondary dressing is determined by wound location, size, depth and user preference. Change the secondary dressing as needed to maintain a moist, clean wound area. Frequency of secondary dressing change will be dependent upon volume of exudate produced and type of dressing used. As healing occurs, sections of PuraPly® Antimicrobial Wound Matrix may gradually peel and may be removed during dressing changes. Do not forcibly remove sections of PuraPly® Antimicrobial Wound Matrix that may adhere to the wound. Alternatively, the PuraPly® Antimicrobial Wound Matrix may form into a caramel-colored gel, which can be rinsed away with gentle irrigation. On inspection, if PuraPly® Antimicrobial Wound Matrix is no longer covering the wound, place an additional piece of PuraPly® Antimicrobial Wound Matrix over the wound. The wound should be reevaluated on a weekly basis for PuraPly® Antimicrobial reapplication.
Organogenesis is a global leader in advanced wound care, offering a comprehensive portfolio of regenerative medicine products capable of supporting patients from early in the wound healing process through to wound closure, regardless of wound type.