Cytal™ Wound Matrix (1-Layer, 2-Layer, 3-Layer, 6-Layer)

Cytal™ Wound Matrix is a sterile, porcine-derived, naturally-occurring lyophilized extracellular matrix in sheet form that maintains and supports a healing environment for wound management.

ACell, Inc.

ACell, Inc. offers Cytal™ and MicroMatrix® products that maintain and support a healing environment through constructive remodeling. Indicated for acute and chronic wounds.

Toll free:(800) 826-2926 Fax:(410) 715-4511 Website: www.acell.com

Benefits

• 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

Indications

Cytal™ Wound Matrix is intended 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, and skin tears) and draining wounds. This device is intended for one-time use.

Contraindications

Contraindicated for use on patients with known sensitivity or allergy to porcine materials and third-degree burns.

Warnings and Precautions

Cytal™ Wound 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.

Storage Requirements

Store in a clean, dry environment between 15°C-35°C (59°F-95°F) in unopened and undamaged package.

How Supplied/Sizing

3cmx3(1/2)cm to 10cmx15cm.

HCPCS Code

Q4119

Product features

check_circle Assigned HCPCS code

cancel Minimally manipulated

cancel Dehydrated

cancel Desiccated

cancel Flowable

cancel Micronized

check_circle Sheet form

cancel Requires refrigeration

cancel Shelf life greater than 2 years

cancel Shelf life limited

check_circle Indicated for acute wounds

check_circle Indicated for chronic wounds

check_circle Indicated for diabetic ulcers

check_circle Indicated for pressure ulcers

cancel Indicated for second-degree burns

check_circle Indicated for surgical wounds

cancel Indicated for third-degree burns

check_circle Indicated for venous ulcers

cancel Contact manufacturer for usage guidelines

Other features

check_circle Educational Material Available

check_circle Free Samples/Trials Available

check_circle Published Clinical Article Available

Recommended Use

Chronic Wounds
Diabetic Foot
Pressure Ulcers
Superficial Wounds
Surgical Wounds
Venous Ulcers

Mode of Use/Application

Clean wound bed by removing necrotic tissue and scar tissue to obtain fresh tissue edges. Irrigate excessive exudates and control bleeding. Remove Cytal™ Wound Matrix from container using standard aseptic methods. Cut device slightly bigger than area of wound to be covered. Rehydrate Cytal™ Wound 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™ Wound 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.

Removal & Change Frequency

Inspect wound for adverse reactions every seven days; remove exudates and apply new Cytal™ Wound Matrix to any non-covered wound areas. Do not remove any remaining device that is intact on wound surface. As Cytal™ Wound Matrix is resorbed, it may form a caramel-colored gel. Rinse wound surface gently leaving the caramel-colored gel intact and reapply another device. Repeat wound care follow-up process weekly until wound has epithelialized. Monitor tissue surrounding edges of wound.

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