AmnioExCel

Clinical Protocol
1. Preparation and Surgical Use
a. Wound Bed Prep i. Ensure wound is clear of any clinical sign of infection. ii. Debride wound to a viable wound base. b. Removal of AmnioExcel i. Open the peelable corner of the outer pouch (not sterile) and present the inner pouch (contains AmnioExCel and is sterile) onto the sterile field. ii. Slowly peel the corner of the inner peel pouch and grasp AmnioExCel along with mesh with fingers or sterile forceps.

NOTE: Take special care when removing AmnioExCel from the internal pouch as the tissue is extremely thin and lightweight. USE GOOD FORCEPS! 2. AmnioExCel Preparation
a. Use sterile dry scissors to cut AmnioExCel and mesh to fit so that it overlaps the wound margins by approximately 1 2 mm. b. AmnioExCel can be fenestrated in cases of copious exudate.

3. AmnioExCel Orientation
a. AmnioExCel should be placed with tissue in contact with the wound (mesh anterior to the tissue) for proper orientation. b. AmnioExCel can be hydrated while adhering to the wound site with sterile saline solution. Take care not to displace AmnioExCel from the wound while hydrating. c. AmnioExCel can be fixated to wound site via suture and/or tissue adhesives.

4. Primary Dressing
a. AmnioExCel should be covered with a non-adherent topical layer. b. AmnioExCel and topical dressing should not be disturbed for at least 2 weeks if possible. c. Infections that occur should be treated according to facility protocol.

5. Secondary Dressing
a. AmnioExCel healing is expedited in a moist wound environment. Use appropriate moisture management dressings for the wound type and treatment ideology.

6. Support Therapies
a. AmnioExCel is compatible with compression, negative pressure and offloading therapies. b. AmnioExCel is also compatible with hyperbaric oxygen therapy.

7. Re-application of AmnioExCel
a. If clinical signs of slowing wound margin reduction exist, re-apply AmnioExCel per same protocol. Copyright 2012 BioPathways/LUXmed. Confidential Company Material. All Rights Reserved.