Cytal™ Burn Matrix is a sterile, porcine-derived, naturally-occurring lyophilized extracellular matrix in sheet form that maintains and supports a healing environment for wound management.
• Maintains and supports a healing environment through constructive remodeling
• Comprised of naturally-occurring urinary bladder matrix
• Contains basement membrane and numerous collagens
• Maintains an intact epithelial basement membrane
• Non-crosslinked wound management scaffold
• Appropriate for acute and chronic wounds
• Complements standard of care
• Fenestrated sheets
Cytal™ Burn Matrix (meshed sheets) are intended for the management of wounds including: second-degree burns, 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, skin tears) and draining wounds. This device is intended for one-time use.
Contraindicated for use on patients with known sensitivity or allergy to porcine materials and third-degree burns.
Cytal™ Burn Matrix is intended for one-time use. Do not re-use or sterilize. Do not use if package seal has been broken. Complications and reactions are possible with any soft tissue repair, including but not limited to: infection, increased chronic inflammation, allergic reaction, unexplained fever or chills, excessive redness, pain or swelling.
Store in a clean, dry environment between 15°C-35°C (59°F-95°F) in unopened and undamaged package.
Burns
Clean wound bed by removing necrotic tissue and scar tissue to obtain fresh tissue edges. Irrigate excessive exudates and control bleeding. Remove Cytal™ Burn Matrix from container using standard aseptic methods. Cut device slightly bigger than area of wound to be covered. Rehydrate Cytal™ Burn Matrix in room temperature sterile saline or sterile lactated Ringer's solution in a sterile dish for five minutes prior to use.
Large wound: More than one device may be needed to cover wound area. Overlap Cytal™ Burn Matrix edges slightly to ensure complete coverage.
Wet wound: Cover device with non-adherent dressing such as petrolatum gauze, followed by application of an absorptive dressing such as a calcium alginate. Secure dressings to wound site.
Dry wound: The non-adherent dressing should be followed by application of a hydrogel dressing to keep wound moist. Secure dressings to wound site. Keep device and wound bed moist.
Inspect wound for adverse reactions every seven days; remove exudates and apply new Cytal™ Burn Matrix to any non-covered wound areas. Do not remove any remaining device that is intact on wound surface. As Cytal™ Burn Matrix is resorbed, it may form a caramel-colored gel. Rinse wound surface gently leaving the caramel-colored gel intact and re-apply another device. Repeat wound care follow-up process weekly until wound has epithelialized. Monitor tissue surrounding edges of wound.
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