OASIS® ULTRA Tri-Layer Matrix is a natural extracellular matrix (ECM) derived from 3 layers of porcine small intestinal submucosa (SIS) technology. The technology provides an intact three-dimensional extracellular matrix which allows for host cell migration. The three-layer construct is designed with surgeons in mind for increased strength, thickness, and durability. These attributes provide handling/flexibility and more fixation options.
• Increased strength and thickness allows for more fixation options, including sutures and staples
• Proven management of a wide array of acute and chronic wounds
• Comes ready to apply
• Easy to trim to size and shape of wound
• Minimally processed and sterilized
• Can be used in a variety of settings, including long-term, outpatient, and at-home care
• Long-term storage without compromising ability to support healing
• Naturally derived structure that supports healing process
• Incorporated and absorbed into the wound
• Contains components similar to those found in the human dermis
OASIS® ULTRA Tri-Layer Matrix is indicated for the management of wounds including partial- and full-thickness wounds, pressure injuries, venous ulcers, chronic vascular ulcers, tunneling and undermining wounds, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, and surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence).
This device is derived from a porcine source and should not be used in patients with known sensitivity to porcine material. This device is not indicated for use on third-degree burns.
Do not re-sterilize. Discard all open and unused portions of OASIS® ULTRA Tri-Layer 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.
OASIS® ULTRA Tri-Layer Matrix should not be applied until excessive exudate, bleeding, acute swelling, and infection are controlled.
The following complications are possible. If any of these conditions occur, the device should be removed:
Chronic inflammation (initial application of wound dressings may be associated with transient, mild, localized inflammation)
Excessive redness, pain, swelling, or blistering
This device should be stored in a clean, dry location at room temperature.
Chronic Vascular Ulcers
Partial- and Full-Thickness Wounds
Surgical Wounds (Donor Sites/Grafts, Post-Mohs Surgery, Post-Laser Surgery, Podiatric, Wound Dehiscence)
Tunneled or Undermined Wounds
Trauma Wounds (Abrasions, Lacerations, Second-Degree Burns, Skin Tears)
Prepare the wound bed to make it free of exudate and devitalized tissue. Wait for any bleeding to stop before applying OASIS® ULTRA Tri-Layer Matrix.
Measure the wound and select the appropriately sized sheet of dry OASIS® ULTRA Tri-Layer Matrix. Cut the sheet to size and position it to cover the wound surface, extending slightly beyond the margins. If multiple sheets are necessary, overlap the edges slightly. As required, anchor OASIS® ULTRA Tri-Layer Matrix using the physician's preferred fixation method (eg, STERI-STRIP™, tissue sealant, bolsters, sutures, or dissolvable clips).
Apply a non-adherent primary wound dressing over OASIS® ULTRA Tri-Layer Matrix. Gently rehydrate OASIS® ULTRA Tri-Layer Matrix with sterile saline.
Select an appropriate secondary dressing, based on the type of wound and the amount of exudate. Use a multilayer compression bandage if necessary.
Assess the wound after 7 days or as necessary. The wound should be free of infection and necrosis. Carefully remove any remaining loose product from around the wound edges as needed.
The primary dressing is usually changed on day 7 to avoid product disruption.
Reapplication is typically necessary every 7 days. Reapply as needed if OASIS® ULTRA Tri-Layer Matrix is no longer covering the wound and it is free of infection and necrosis.
If a gel forms on the wound surface, do not attempt to forcibly remove. Gently rinse the wound surface, leaving the extracellular matrix (ECM) gel intact.
Apply a non-adherent primary wound dressing over OASIS® ULTRA Tri-Layer Matrix. Apply an appropriate secondary dressing (multilayer compression bandage system, total contact cast or other appropriate dressing) that will manage the wound exudate, keep the OASIS® ULTRA Tri-Layer Matrix moist and keep all layers securely in place.
Porcine small intestinal submucosa that provides 3 meshed/fenestrated layers of naturally derived ECM. OASIS® ULTRA Tri-Layer Matrix is supplied sterile in peel-open packages and is intended for one-time use.
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