Prime Healthcare Shasta Regional Medical Center Wound Care

Prime Healthcare Shasta Regional Medical Center Wound Care Clinic The Art & Science of Diabetes Symposium 2017

Prime Healthcare Shasta Regional Medical Center Wound Care Clinic

The Cost of Failure: 20% will develop a wound… Confidential and proprietary information 3 © 2013 Healogics, Inc. All Rights Reserved

The Cost of Failure: …increasing their risk of amputation by 46% Confidential and proprietary information 4 © 2013 Healogics, Inc. All Rights Reserved

The Cost of Failure: … 27% require a 2 nd amputation within the year Confidential and proprietary information 5 © 2013 Healogics, Inc. All Rights Reserved

The Cost of Failure: …and 50% are dead 5 years later Confidential and proprietary information 6 © 2013 Healogics, Inc. All Rights Reserved

By the Numbers… • Chronic wounds affect 6. 5 million Americans/ year at a treatment cost of $25 billion per year • Additional $39 billion in lost wages/ year • $15. 3 billion estimated expense on wound care products in 2010 (the cost of “success”? ) Confidential and proprietary information 7 © 2013 Healogics, Inc. All Rights Reserved

Diabetic Ulcer Location: plantar aspect of the foot beneath a bony prominence. Appearance: ill-defined borders, prominent callus, and palpable pulses. Confidential and proprietary information 8 © 2013 Healogics, Inc. All Rights Reserved

Diabetic Ulcer Confidential and proprietary information 9 © 2013 Healogics, Inc. All Rights Reserved

DFU- Management Principles • • Off-loading Debridement/ dressing selection (clean, moist wound bed) Evaluate and correct ischemia/osteomyelitis Adjunctive therapy • Skin substitutes • HBOT Confidential and proprietary information 11 © 2013 Healogics, Inc. All Rights Reserved

Skin Subsitutes • Bio-Engineered – Apligraf – Dermagraft • Collagen Wound Matrix – Oasis – Puraply • Amniotic Membrane Allografts – Grafix – Epi. Fix Confidential and proprietary information 12 © 2013 Healogics, Inc. All Rights Reserved

Prime Healthcare Shasta Regional Medical Center Wound Care Clinic

Case Study’s First visit to the Wound Center 11/21/14

Pt came to the WCC with the wound below. Patient was then readmitted for cellulitis and possible associated osteomyelitis and for IV antibiotic and further management. On 12/16/2016 was transferred to Vibra. 12/9/14

• 5/5/2015 - Again admitted to the hospital with DFU and Cellulitis of the right foot. • 8/20/15 – Admitted for heart failure • 2/8/16 – Sepsis from DFU right foot, pt refuses BKA.

9/10/16 – Sepsis from DFU right foot, again refuses BKA. 9/14/16 Surgical debridement in the OR 9/9/16 After surgical debridement in the OR. Pt back at home. Continue to follow in WCC. 9/26/16

First Visit 4/11/16 for DFU Past Medical History: : CVA/TIA/Stroke, Coronary Artery Disease, Diabetes, Gout, High Cholesterol, Hypertension, Leukemia, Myocardial Infarction, Charcot foot Past Surgical History: Angioplasty, Coronary bypass surgery, Orthopedic surgeries foot surgery and History of osteomyelitis, status post tarsal amputation of the right foot.

4/18/16 Tunnel present, I&D done at bedside

4/28/16 New wound dorsal left foot communicates with plantar wound 5/5/16 I&D done from Left dorsal foot wound to plantar wound

5/31/16 Clean and granulating 1 st Cellular Tissue product used Total of 6 applied through 8/16/16 9/27/16 7/19/16 Total contact casting started and done weekly.

DFU 8/21/14 8/7/15 12/7/15

Dermagraft is a 3 -dimensional human dermal substitute 1 References: 1. DERMAGRAFT Directions for Use. Organogenesis. 2013. 2. Marston WA, et al. Diabetes Care. 2003; 26(6): 1701 -1705. 3. Data on file. Shire Regenerative Medicine. 2013. 4. US Food and Drug Administration. Medical Devices. Premarket Approval. http: //www. fda. gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default. htm. Accessed February 6, 2013. 5. Roberts C, et al. Can J Plast Surg. 2002; 10(suppl A): 6 A-13 A. 6. Loots MAM, et al. J Invest Dermatol. 1998; 111(5): 850 -857. 7. Margolis DJ, et al. Diabetes Care. 1999; 22(5): 692 -695. 8. Brem H, et al. Plast Reconstr Surg. 2006; 117(7 suppl): S 193 -S 209. 9. Gentzkow GD, et al. Diabetes Care. 1996; 19(4): 350 -354.

• Chronic diabetic foot ulcers (DFUs) demonstrate impaired healing that results from multiple pathological factors (eg, vascular insufficiency, altered cellular activity, and a dysfunctional extracellular matrix), leading to a deficient wound bed, which often fails to respond to conventional therapy alone 5 -7 • Dermagraft helps to restore the compromised DFU dermal bed to facilitate healing by providing a substrate over which the patient’s own epithelial cells can migrate to close the wound 5 – Composed of human fibroblasts, an extracellular matrix, and a bioabsorbable polyglactin mesh scaffold 1 – Cryopreserved, 3 -dimensional, human dermal substitute 1 – Allows for serial applications without the need for removal of the product from the wound 1 References: 1. DERMAGRAFT Directions for Use. Organogenesis. 2013. 2. Marston WA, et al. Diabetes Care. 2003; 26(6): 1701 -1705. 3. Data on file. Shire Regenerative Medicine. 2013. 4. US Food and Drug Administration. Medical Devices. Premarket Approval. http: //www. fda. gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default. htm. Accessed February 6, 2013. 5. Roberts C, et al. Can J Plast Surg. 2002; 10(suppl A): 6 A-13 A. 6. Loots MAM, et al. J Invest Dermatol. 1998; 111(5): 850 -857. 7. Margolis DJ, et al. Diabetes Care. 1999; 22(5): 692 -695. 8. Brem H, et al. Plast Reconstr Surg. 2006; 117(7 suppl): S 193 -S 209. 9. Gentzkow GD, et al. Diabetes Care. 1996; 19(4): 350 -354.

Product quality specifications and cryopreservation • Prior to release, each lot of Dermagraft must pass USP sterility (14 -day), endotoxin, and mycoplasma tests; each lot meets release specifications for collagen content, DNA, and cell viability 1 • The human fibroblast cells are from a qualified cell bank 1 • Manufactured with sterile components under aseptic conditions within the final package 1 • Dermagraft must be stored continuously at -75°C ± 10°C 1 and has a shelf-life of up to 6 months from the time of cryopreservation 3 • Cryopreservation enables testing prior to shipment and helps with inventory control 5 • Supplied frozen in a clear pouch containing one piece of approximately 2 in × 3 in (5 cm × 7. 5 cm) for a single-use application 1 • To ensure the delivery of metabolically active, living cells to the patient’s wound, do not hold Dermagraft at room temperature for more than 30 minutes 1 References: 1. DERMAGRAFT Directions for Use. Organogenesis. 2013. 2. Marston WA, et al. Diabetes Care. 2003; 26(6): 1701 -1705. 3. Data on file. Shire Regenerative Medicine. 2013. 4. US Food and Drug Administration. Medical Devices. Premarket Approval. http: //www. fda. gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default. htm. Accessed February 6, 2013. 5. Roberts C, et al. Can J Plast Surg. 2002; 10(suppl A): 6 A-13 A. 6. Loots MAM, et al. J Invest Dermatol. 1998; 111(5): 850 -857. 7. Margolis DJ, et al. Diabetes Care. 1999; 22(5): 692 -695. 8. Brem H, et al. Plast Reconstr Surg. 2006; 117(7 suppl): S 193 -S 209. 9. Gentzkow GD, et al. Diabetes Care. 1996; 19(4): 350 -354 .