Integra® Flowable Wound Matrix is an advanced wound care device comprised of a granulated Integra® Wound Matrix, which consists of collagen and glycosaminoglycan. The Integra® Flowable Wound Matrix is hydrated with saline prior to application. It is designed for use in deep soft tissue or tunneling wounds.
• Gel-like consistency allows intimate contact between the grafting material and wound bed
• Composition and method of administration allows for complete coverage in deep crevice wounds
• Provides a resorbable scaffold on which cells can attach, migrate, proliferate and differentiate
Integra® Flowable Wound Matrix is indicated for the management of wounds including: 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. The device is intended for one-time use.
This device should not be used in patients with known sensitivity to bovine collagen or chondroitin materials. This device is not indicated for use in third-degree burns.
Do not resterilize. Discard all opened and unused portions of the device. Do not use if package seal is broken.
Complications are possible with the use of wound dressings including infection, chronic inflammation, allergic reaction, excessive redness, pain or swelling.
Room temperature with a 18-month shelf life.
Inspect all packaging integrity including protective wrapping, syringes and tip caps. Do not use if packaging is damaged, or tip cap is missing or not fully attached to syringe. Visually inspect the empty syringe. Do not use if empty syringe contains cracks or visible particulate matter. Prepare wound bed 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.
Peel open all three pouches (dry granulated collagen syringe pouch, empty sterile syringe pouch and the luer lock connector accessory pouch). Pour saline into sterile container and draw 3ml of saline into the empty syringe. Remove tip cap from the 6ml dry collagen syringe and attach luer lock connector to the collagen syringe. Attach the syringe containing saline to the other end of the luer lock connector. Hold both syringes in your hands securely. Dispense all saline fluid into the dry collagen syringe. Depress plungers back and forth at least 15 times to prepare the Integra® Flowable Wound Matrix.
Consider the flowable wound matrix mixed when product appearance is consistent and homogeneous and all the product can be moved from one syringe to the other. Ensure all the mixed material is moved into the 6ml collagen syringe (white plunger). Remove the luer lock connector and the empty syringe while holding the 6ml syringe. Attach flexible injector tip securely to the 6ml syringe. Slowly depress plunger to 3ml to remove air pockets.
When dispensing Integra® Flowable Wound Matrix, first determine the location of the base of the wound bed utilizing the flexible injector. Upon dispensing product into the wound, avoid pressing the injector tip directly against the base of the wound to ensure the product is not prevented from exiting the flexible injector.
After application, use an optimal secondary dressing to maintain matrix adherence and protect the wound area. The optimum dressing is determined by wound location, size, depth and user preference. On inspection, if the wound is not completely filled, use an additional dose of the Integra® Flowable Wound Matrix to complete the procedure.
Change the dressing as needed. Frequency of dressing changes will be dependent upon volume of exudate produced, type of dressing used and the clinician's need to inspect the wound bed for signs of infection or healing.
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