Excellagen Package Insert
Excellagen® is a ready to use topical wound management product composed of highly purified, formulated, fibrillar type I collagen (2.6%) derived from bovine skin. When applied following debridement as directed, the biodegradable collagen matrix provides scaffold for cellular migration.
INDICATIONS FOR USE
Excellagen 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/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds. The device is packaged in single-use only syringes.
Excellagen should not be used in individuals with a known sensitivity to bovine collagen.
Do not reuse. Discard all opened or partially used syringes of Excellagen.
Do not freeze. Discard device if material freezes. Visual evidence of freezing would include development of large clumps, a highly granular appearance and phase separation (distinct areas of clear liquid separated from the white collagen).
Inspect before use. Discard if there are changes in color, viscosity or homogeneity of contents. The collagen contents of the syringe should be homogeneously opaque, white to off-white in color, and without gaps, cracks or phase separation (distinct areas of clear liquid separated from the white collagen gel). Exposure to temperatures above the recommended storage conditions of 36 ͦ-46 ͦ F / 2°-8°C may cause the collagen to denature. Evidence for denaturation includes reduced viscosity and decreased opacity (fully denatured collagen is clear like water).
The Excellagen syringe contents are sterile. Do not use if syringe tip cap is missing or not fully attached.
The flexible catheter applicator is sterile. Do not use if the package seal is broken.
Discard device if mishandling has caused possible damage or contamination.
Excellagen should not be applied until excessive exudate, excessive bleeding, acute swelling, and infection are controlled.
Sharp debridement or excision should be performed prior to application of Excellagento remove necrotic tissue that may cause infection and to allow a small influx of blood into the wound.
The following complications are possible with the use of wound management products: infections, chronic inflammation (initial application of wound dressings may be associated with transient, mild, localized inflammation), allergic reaction, excessive redness, pain, or swelling. If any of these conditions occur, the device should be removed.
INSTRUCTIONS FOR USE
When clinically necessary, sharp debridement should be performed prior to application of Excellagento remove necrotic tissue that may cause infection and to allow a small influx of blood into the wound.
Open a product pouch and remove the Excellagen syringe and catheter applicator.
Remove tip cap from the Excellagen syringe. Open the catheter package, pull off and discard the clear cover. Grasp the applicator tip hub and slide off the stainless needle. Discard the stainless needle. Attach the sterile flexible applicator tip to the Excellagen syringe by twisting the hub onto the syringe in a clockwise direction (do not touch the flexible tip).
Spread Excellagen onto the entire wound surface, including the edges. For tunneled/undermined wounds, first determine the base of the wound bed utilizing the flexible applicator tip, and then fill the tissue voids. Avoid pressing the flexible applicator tip against the base of the wound to ensure the product is not prevented from exiting the applicator tip. Apply directly into tunneled or undermined areas. Discard unused material, if any.
After application, overlay with a non-adherent dressing to maintain product adherence and to protect the wound area. Additional layers of gauze or foam dressings may be applied on top of the non-adherent dressing to manage exudate. Secure with outer stretch bandage.
Change the outer dressings as needed to manage exudate.
Change the non-adherent dressing and perform standard wound care procedures and assessments on a weekly basis.
If the wound is not completely healed, Excellagenmay be reapplied once per week.
Each box also contains: one single-use syringe and one flexible catheter applicator tip packaged in a sealed pouch; four Product Information labels and a Package Insert.
Store at standard refrigeration temperature (36°- 46°F; 2°- 8°C).
Federal law restricts this device to sale by or on the order of a physician or licensed practitioner
Olaregen Therapeutix Inc.
1001 Avenue of the Americas, 2nd Floor
New York, NY 10018
Product Ordering & Customer Service: 1-833-4AWOUND (1-883-429-6863)
Technical & Medical Support Services: 1-844-WOUNDS4 (1-844-968-6374)