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OASIS® ULTRA Tri-Layer Matrix
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.
Smith+Nephew, Inc.
Smith+Nephew, Inc.
For over 150 years, Smith+Nephew has taken a pioneering approach to product design and services, helping to reduce the human and economic costs of wounds.
Advanced Wound Bioactives
(Includes Collagenase SANTYL* Ointment, PROSHIELD* Foam & Spray Incontinent & Total Body Cleanser, PROSHIELD* Plus Skin Protectant, REGRANEX* (becaplermin) Gel 0.01%)
Toll-free: (800) 441-8227
Fax: (817) 900-4100
Email: snbiocc@smith-nephew.com
Cellular- and/or Tissue-Based Products
(Includes GRAFIX PL*, GRAFIX*, STRAVIX*, OASIS® MICRO, OASIS® Wound Matrix, OASIS® Burn Matrix, and OASIS® Ultra Tri-Layer Matrix)
Website: www.stravixpl.com
Phone: (888) 674-9551
Fax: (443) 283-4419
Email: osiris-biosurgerycs@smith-nephew.com
Advanced Wound Care or Devices
(PICO* Single Use Negative Pressure Wound Therapy, RENASYS* TOUCH Negative Pressure Wound Therapy, RENASYS* GO Negative Pressure Wound Therapy)
Toll-free: (800) 876-1261
Fax: (727) 392-6914
Email: customercare.wound@smith-nephew.com
*Trademark of Smith+Nephew
Fenestrated: 3cmx3.5cm, 3cmx7cm. Meshed: 5cmx7cm, 7cmx10cm, 7cmx20cm.
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.
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:
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.
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.