ECM3 Collagen Particles are a white to off-white, absorbent, microfibrillar particulate collagen matrix intended for wound management. The dressing provides a physiologically favorable moist wound environment. When interacting with the wound fluid, the product immediately begins to absorb the exudates. The ECM3 Collagen Particles are applied directly to the secreting wound and protects the wound bed and delicate new tissue. In addition, the device, being comprised of hydrophilic, microfibrillar collagen, has intrinsic hemostatic properties, which can be used to control minor bleeding.
INDICATIONS FOR USE: ECM3 Collagen Particles are indicated for the management of moderately to heavily exuding wounds and to control minor bleeding. ECM3™ Collagen Particles may be used for the management of exuding wounds such as: pressure ulcers, venous stasis ulcers, diabetic ulcers, acute wounds, e.g., trauma and surgical wounds, and partial-thickness burns.
DIRECTIONS: (For use under the guidance of a healthcare professional).
TO APPLY:
- Cleanse the wound, apply medication to the wound if indicated.
- Ensure the intact skin surrounding the wound is dry.
- Apply the particles ¼” inch thick to the wound surface. Do not pack the wound tightly to allow for the absorbency of exudate and the expansion of fibrillar particles.
- Cover with an absorbent dressing.
CHANGING THE DRESSING:
- The dressing should be changed as indicated by the amount of drainage (for example, if drainage seeps through the back of the dressing, or if the edge of the dressing becomes loose), and instructions provided with the absorbent cover dressing.
- Remove the cover dressing.
- Cleanse the wound.
- Dry surrounding intact skin
- Repeat product application step three listed above as needed. Do not reuse or reseal.
- Discard open packaging and unused product.
PRECAUTIONS:
- ECM3 Collagen Particles are intended for topical use only. Avoid inhalation and eye contact. For single use only
- Do not reseal or re-sterilize. Discard open packaging and unused product per facility hazardous waste protocols.
- Some reactions such as transitory pain, bleeding, blistering, swelling and redness have been reported in isolated cases using a similar product. If these conditions continue for more than 3-5 days, discontinue use of the product and notify physician
- Wounds may appear to be larger during the first several days of treatment due to reduction of swelling.
- An increase in drainage may be seen in the first several days of treatment.
CONTRAINDICATIONS: This product is not indicated for patients that have a known allergy or sensitivity to bovine-derived materials (e.g., milk, beef products, leather, etc.).
STORAGE: Store dry at room temperature.
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