INTEGRA BILAYER WOUND MATRIX

1 INTEGRA . BILAYER . WOUND . MATRIX . TREATMENT GUIDELINES. Collagen Soft Tissue Technology Page 1 INTEGRA BILAYER WOUND MATRIX INTEGRA BILAYER WOUND MATRIX Page 2. Product and Procedure Overview INTEGRA BILAYER WOUND MATRIX is an advanced WOUND care device comprised of a porous MATRIX of cross -linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone layer). The semi-permeable silicone membrane controls water vapor loss, provides a flexible adherent covering for the WOUND surface and adds increased tear strength to the device.

2 The collagen-glycosaminoglycan biodegradable MATRIX provides a scaffold for cellular invasion and capillary growth. These guidelines have been developed based on the collective best practices of experienced users of the INTEGRA BILAYER WOUND MATRIX (IBWM). They are intended to be a quick reference to important information on the use of the IBWM and as a supplement to the Physician Training Modules and your unit's own protocols. For additional information contact your Reconstructive Sales Specialist or a Technical Representative at 877-444-1122 or 609-275-9004.

3 Page 3 INTEGRA BILAYER WOUND MATRIX INTEGRA BILAYER WOUND MATRIX Page 4. Table of Contents PROCEDURE #1: EXCISION AND 6. Operating Room 6. Outpatient Clinic Supplies .. 6. Estimating Number of 7. II. Intraoperative Preparing for Application of 9. Product 9. WOUND Bed 10. Application of IBWM .. 12. III. Post-Operative care Guidelines ..15. Dressing Changes .. 15. 15. Positioning and Moving the Patient .. 16. Physical Therapy/Occupational 16. Neodermis 17. Home 17. Negative Pressure WOUND Therapy (NPWT).. 18. Complications and 20. Procedure #2: SILICONE REMOVAL AND EPIDERMAL 23.

4 Planning for Epidermal Grafting (if necessary).. 23. Removal of 23. Inspect and Prepare the 23. Harvesting the Thin Epidermal 24. Placing the Epidermal 24. Epidermal Autograft Dressings and 24. 26. Photographs and 26. Clinical 27. Product 29. Dressing 31. Tissue 33. Tissue Remodeling 35. Silicone Removal and Epidermal 37. Page 5 INTEGRA BILAYER WOUND MATRIX Table of Contents Large 39. Small, Late-Forming 39. Fluid 40. Non-Take/Shearing of 40. 41. Case Achilles 42. Heel 43. Traumatic Degloving Calcaneal 44. Leg 45. Hypercoagulable 47.

5 Package INTEGRA BILAYER WOUND MATRIX Page 6. Procedure #1: EXCISION AND APPLICATION. I. Pre-Operative Guidelines Operating Room Supplies In addition to standard OR supplies for a procedure, the following supplies should be available in the OR: Electrocautery instrumentation ( , bovie, double plug, bipolar). for pin-point coagulation Excisional Devices ( , scalpel, Versajet Hydrosurgery System, curettes, Dermabrader). Antimicrobial agents/dressings*. Compression dressings/wraps Non-crushing Mesher** (if planning to mesh IBWM 1:1).

6 Note: pie-crusting is also acceptable Splints and braces Outpatient Clinic Supplies In addition to standard supplies for a procedure, the following supplies should be available in the clinic: Hemostatic agents ( , epinephrine soaked gauze, electrocautery, thrombin spray). * ( , Acticoat silver impregnated dressing, Sulfamylon Solution 5%, silver nitrate solution ). ** A non-crushing mesher refers to a fixed ratio mesher that is known not to crush or tear the MATRIX . ( , Brennen Mesher). Page 7 INTEGRA BILAYER WOUND MATRIX Excisional devices ( , scalpel, Versajet Hydrosurgery System, curettes).

7 Antimicrobial agents/dressings*. Compression dressings/wraps Non-crushing Mesher** (if planning to mesh IBWM 1:1);. Note: pie-crusting is also acceptable Immobilization/off-loading devices ( , bolsters, splints, boots, casts, braces). Estimating Number of Sheets Estimate the number of sheets of IBWM you will need using the following guidelines and chart: 1. Determine size of area to be covered.( , 9% TBSA for an adult or cm2). 2. Determine product size ( , 20 x 25 cm). The following chart provides size suggestions based on anatomical site.

8 If you are planning to mesh the IBWM, it is suggested that you use the 10 x 25 cm (4 x 10 inch) or smaller size. 3. Calculate number of sheets by dividing Surface Area by Sheet Area ( , 1750 cm2 / 500 cm2 = sheets). 4. Due to difficulties in estimating surface area and losses due to trimming, it is often advisable to allow for an additional 10%. ( , sheets X = sheets). * ( , Acticoat silver impregnated dressing, Sulfamylon Solution 5%, silver nitrate solution ). ** A non-crushing mesher refers to a fixed ratio mesher that is known not to crush or tear the MATRIX .

9 ( , Brennen Mesher). INTEGRA BILAYER WOUND MATRIX Page 8. Approximate surface area per sheet of IBWM. 2 x 2 inches = 25 sq. cm. 4 x 5 inches = 125 sq. cm. 4 x 10 inches = 250 sq. cm. 8 x 10 inches = 500 sq. cm. Estimated number of IBWM sheets needed per adult anatomy Face = 1-2, 8 x 10's Neck = 2-3, 4 x 10's Anterior trunk = 4, 8 x 10's; 1-3, 4 x 10's Posterior trunk = 4-5, 8 x 10's; 1-3, 4 x 10's Upper extremities = 3-4, 8 x 10's; 1-4, 4 x 10's Buttocks = 2-4, 8 x 10's Lower extremities = 4-8, 8 x 10's; 1-6, 4 x 10's Hands/feet = 1-3, 4 x 10's; 1-3, 4 x 5's Page 9 INTEGRA BILAYER WOUND MATRIX II.

10 Intraoperative Guidelines Preparing for Application of IBWM. In the outpatient setting, a local anesthetic or nerve block may be required prior to WOUND preparation. Remove all excised tissue and contaminated OR equipment from the sterile patient field before application begins. Re-drape area and re-gown as needed. Change gloves before handling IBWM. New sterile instruments are required for IBWM. placement, shaping and cutting. Product Preparation Fill a basin with 1 liter of sterile saline. The circulating nurse opens the outer Tyvek pouch.