Excellagen Package Insert

DESCRIPTION

Excellagen® is a ready to use topical wound care 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 is designed to support a favorable wound healing environment. 

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.

CONTRAINDICATIONS

Excellagen should not be used in individuals with a known sensitivity to bovine collagen.

PRECAUTIONS

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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 gel).

  • 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 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

1.    Perform sharp debridement of the wound bed to ensure that wound is free of debris and necrotic tissue. Allow a small influx of blood into the wound before applying Excellagen. 

2.    Open a product pouch and remove the Excellagen syringe and catheter applicator.

3.    Remove tip cap from the Excellagen syringe. Open the catheter package, and pull off and discard the clear cover.  Grasp the yellow applicator tip hub and slide off of 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).

4.    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.

5.    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. 

6.    Change the outer dressings as needed to manage exudate.

7.    Change the non-adherent dressing and perform standard wound care procedures and assessments on a weekly basis.

8.    If the wound is not completely healed, Excellagen may be reapplied once per week. 

 

HOW SUPPLIED

Excellagen is supplied in a box consisting of:  Four single-use 1.0 cc syringes, each containing 0.5 cc of formulated collagen, and four single-use sterile catheter applicator tips. One Excellagen syringe and one catheter applicator tip are packaged together in a heat-sealed pouch (four pouches per box).  Each box also contains four product information label sheets, and one Package Insert.

Product Code

EX0104

Size

1.0 cc

Volume

0.5 cc

Quantity

4 units/box

STORAGE

Store at standard refrigeration temperature (36°-46°F; 2°-8°C).  Avoid freezing.

CAUTION

Federal law restricts this device to sale by or on the order of a physician or licensed practitioner.

MANUFACTURED FOR

Olaregen Therapeutix Inc.
1001 Avenue of the Americas, 2nd Floor
New York, NY 10018

www.Excellagen.com