What s New in Wound Care? Meet Our Fantastic Four

What s New in Wound Care? Meet Our Fantastic Four Nadia Din, DPM Kadin Foot & Ankle Center Medford, NJ

Presenter Disclosures Dr. Nadia Din Kadin Foot & Ankle Center No relationships to disclose

What is Stravix? Stravix is a viable cryopreserved human placental tissue comprised of umbilical amnion and Wharton s jelly Contains collagen and HA-rich extracellular matrix, growth factors, and viable cells native to the tissue. Designed to be used as a surgical covering or wrap for damaged or inadequate integument Can be used over tendon

Benefits Anti-adhesion and anti-inflammatory barrier aids natural wound repair, reduces inflammation, reduces scarring, and protects from infection Designed for application directly to acute and chronic wounds Thicker and stronger than amnion alone Immune neutral Alternative to autologous skin grafting that eliminates the pain, comorbidities and procedure time associated with obtaining autologous grafts

Indications Limited to the homologous use as a wound cover or surgical wrap. The product may be used to cover or wrap acute and chronic wounds, including but not limited to: diabetic foot ulcers, venous leg ulcers, pressure ulcers, dehisced surgical wounds, acute surgical wounds, Pyoderma Gangrenosum and Epidermolysis Bullosa. may be used in wounds encompassing both upper extremity and lower extremity acute and chronic wounds. naturally conforms to complex anatomies and may be used over exposed bone, nerves, tendon, joint capsule, muscle, hardware, and surgical mesh. Contraindications There are no known contraindications

Cryopreserved placental tissues have been shown to be beneficial in supporting natural wound repair Serve as a barrier from the environmental and thus protect the tissue from infection Reduce inflammation Reduce scarring by supporting wound closure without excessive fibrosis

Case Study 64 year female Type 2 diabetes, History of CVA with Right sided weakness, S/P ORIF of Ankle o Non-Insulin dependent Type 2 diabetes with Neuropathy o Non-palpable pedal pulses and ABI are Right 1.2 and Left 1.20; 80% distal superficial femoral artery stenosis lesion was successfully traversed and treated with 5x80 mm drug-coated balloon angioplasty o o o o Flow in the entire length of the posterior tibial artery could not be restored Presented with dehiscence of wounds following ORIF of ankle The treatment included wound debridement, NWPT, and application of Stravix Initial wound was 17.0 x 4.5 cm and is now healed

The Medical Fish Skin Company

Acelullar fish skins is used for wound healing Fish skin is harvested from wild Atlantic cod. Cells are gently removed from the skins Intact fish skin remains, with all components preserved; proteins, glycans and fats (including Omega3s) The graft is applied to human wounds were it recruits stem cells and facilitates tissue regeneration

Skin substitute with Omega3 Molecules in human skin Collagens Elastin Laminin Fibronectin Proteoglycans (e.g. decorin) Glycosaminoglycans Lipids Molecules in acellular fish skin Collagens Elastin Laminin Fibronectin Proteoglycans Glycosaminoglycans Lipids (high proportion being Omega3 s)

Advantages of fish skin compared to mammalian tissues Fish Skin Minimal Processing No viral risk Acellular Fish Skin Intact, strong, suturable Structure Preserved Proteins, Glycans and Fats Preserved Omega3 fatty acids Mammalian Tissue Intensive Processing Substantial viral risk Collagen Most structural components washed away with strong detergents Only the most non-soluble collagens remain

Human- and Fish Skin Structural Comparison Acellular Fish Skin Human Skin Fundamental structure is similar The key difference is: Scales (all removed) instead of hairs Omega3 1 µm 1 µm Fish skin: >30% Human skin: <1% Amniotic Membrane: <1% Rakers S. Et al. Fish matters : the relevance of fish skin biology to investigative dermatology. Experimental Dermatology 2010; 19: 313 324.

Why do we look at cell ingrowth? The most obvious feature of chronic wounds is the failure to re-epithelialize Failure is most often due to keratinocyte migration problems rather than failure to proliferate Failure of migration may occur due to Lack of functional Extracellular Matrix for adherence Excessive inflammation and protease activity Altered cytokine expression and distribution

Cell Migration as marker of functional Extracellular Matrix Achieving cell ingrowth into a skin substitute demonstrates functional ability to Protect ECM components, growth factors and receptors from degradation Modulate inflammatory response Provide scaffold to direct cells into the injury as well as stimulating them to proliferate, differentiate and synthesize new ECM

Discussion on Fish Skin Promising skin substitute for tissue regeneration Has shown faster healing in RCT (n=162) compared to mammalian sourced skin substitutes Rich in Omega3 fatty acids that Promotes cell migration Natural bacterial barrier without cytotoxicity

Key difference of Fish Skin No viral transmission from N. Atlantic Cod to humans Allows for gentle processing retaining Three Dimensional Structure Fatty Acids Omega3 Extracellular Matrix Component No Cultural or religious concerns Wild caught through responsible fisheries

Use of Acellular Fish Skin Biologic cover of the wound that have excessive inflammation, and provides a scaffold for in-growth Wound healing can be slowed down by: Venous insufficiency Diabetes Peripheral arterial disease Or by temporary complicating factors: Inflammation or eczema in skin Infection Too dry or too wet wound environment Pressure Maceration of DFU Bacterial bio-film in venous ulcer

Modes of Action Facilitates healing through tissue regeneration by using unique healing benefits of acellular fish skin and the components thereof. Decrease inflammation by reducing MMP activity Dermal scaffold for cellular in-growth Bacterial barrier Replenishes Omega3 to reduce inflammation Maintains moist wound environment with vapor permeability of human skin Healing of a chronic wounds requires treating the underlying disease. Reduces factors that prevent regular healing to commence and increases healing rate Scaffold for cell in-growth Skin graft

Benefits

On market CE / FDA First fish sourced skin substitute on FDA and CE markets Significant testing required to verify processing method and source material are safe to use and clinically effective FDA 510 k notification Partial and full-thickness wounds * Pressure ulcers * Venous ulcers * Chronic vascular ulcers * Diabetic ulcers * Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) * Surgical wounds (donor sites/grafts, post-mohs surgery, post-laser surgery, podiatric, wound dehiscence). *Draining wounds

ENLUXTRA ENLUXTRA Smart Wound Dressing is the first and only selfregulating super-absorbent fiber wound dressing smart built-in adaptive hydration and selective wound cleansing function

Made of proprietary feedback driven smart polymers adapts its local function to provide optimal treatment for all different wound zones simultaneously, effectively evacuates disintegrated non-viable tissues from the wound

Unlike other moist dressings, continuously evacuates multiple products of natural autolytic debridement from the wound bed. This includes liquefied debris of necrotic tissue and slough, along with harmful microorganisms and disintegrated biofilms. The wound quickly becomes clean, and stays clean. This natural cleansing process works as needed while stays on a wound, and is critical for faster wound healing.

Indications Works for most wounds. With its variable local functionality and superabsorbency Useful for pressure ulcers in any stage, non-healing chronic wounds, postoperative wound complications, diabetic ulcers, heavily draining wounds, venous ulcers, thermal, chemical and radiation burns, wounds with slough and/or necrosis, wounds caused by sickle cell anemia, and many other types of wounds It is hypoallergenic, latex free, bio-inert, non-toxic, contains no active medications

DO NOT pack into wound cavity. DO NOT use wound fillers that shrink (such as alginates) DO NOT use thick and viscous pastes (such as petroleum based products or honey) DO NOT use alginate, hydro-cellulose fibers or collagen dressings under

Usage Slough consists of solid and viscous components. Under this dressing these components get liquefied by natural autolytic process and absorbed by the dressing along with the exudate fluid. The absorbed components are removed as the dressing is changed. Odor reduction follows concurrently. Typically the process takes 3-6 dressing changes to remove slough and odor completely During the slough removal process, change the dressing every 1-2 days to avoid dressing overload by the solid slough components. Follow these steps: Rinse a wound with sterile saline before each dressing application. Change dressing every 1-2 days for the first 1-2 weeks or until slough and odor are 80% removed. Then you may gradually increase wear time to 5-7 days until the wound is healed.

CONTRAINDICATIONS Known sensitivity Heavy arterial bleeding PRECAUTIONS AND WARNINGS Sterile unless damaged or opened Single-use Store at temperatures below 100 F CONSULT A CLINICIAN If you notice any of following: Redness or warmth around the wound Pain or tenderness Unusual odor Excessive drainage or change in color

Case study: Diabetic foot ulcer secondary to gout A 60-year-old female presented with a diabetic foot ulcer secondary to gout and neuropathy on the lateral side of her right foot great toe. Patient is morbidly obese with an existing diabetic plantar ulcer of 7 months duration. Patient comorbidities include type 2 diabetes mellitus, gout, arthritis, venous insufficiency, hypertension, neuropathy

2 weeks 1 month 2 months

The Cutimed TCC Kit Total Contact Casting - Clinically Effective Approach to Healing Dr. David Armstrong and his colleagues' research results showed that TCC heals a higher proportion of wounds in a shorter amount of time over the two other widely used offloading modalities the Removable Cast Walker (RCW) and the half-shoe (P=0.026). Fiberglass and plaster casts retain their rigidity over time, healing the ulcer over a shorter period Wounds achieving less than 53% closure at week four have minimal chance of healing with conventional therapy. 90% of all non-ischemic ulcers without infection Average time to heal = 34 days

By definition, a Total Contact Cast is rigid and is the 'Gold Standard' in the management/healing of DFUs. It incorporates all components necessary for providing a truly rigid casting. Combines specifically chosen and proven casting materials to provide an intimate comfortable close fit and optimized healing environment for a costeffective treatment. Its standardized technique simplifies the implementation of the pressure offloading Gold Standard in the treatment of diabetic foot ulcers.

Indications Non-infected diabetic and neuropathic foot wounds Charcot joint injuries Post-op immobilization following deformity reconstruction Features and Benefits Increased patient compliance Optimized healing environment Standardized technique Convenient all-in-one kit Cost-effective Latex Free

TCC-EZ TCC-EZ is a unique and versatile total contact cast system designed to reduce application time while providing improved healing rates for the diabetic foot ulcer and increased stability and comfort for the patient. Offers a one-piece, roll-on, light weight, woven design that is faster and easier than traditional total contact cast systems. Can be applied in under 10 minutes Enforced Patient Compliance Takes less than ¼ of the amount of time of traditional total contact cast systems Requires minimal training time Lightweight woven design offers a more comfortable fit Allows for customized fit on every application

The Kit

Compared to traditional Total Contact Casts 4 times as many patients were casted in clinics using than traditional total contact cast systems Enforced Patient Compliance Significantly fewer signs of infection Outcomes are comparable or better than traditional total contact cast system

The Total Contact Cast can cut amputation rates in half Total Contact Cast patients have half the amputation rate (Non-Total Contact Cast 5.2%, Total Contact Cast 2.2%) The most used method of off-loading employed by practitioners is the least effective (Surgical shoe) Only 3.7% of eligible Diabetic Foot Ulcers received a Total Contact Cast

Questions

References Armstrong, D., et al. Off-loading the diabetic foot wound. Diabetes Care 2001;24: 1019-22 Cavanagh PR, Owens TM. Nonsurgical strategies for healing and preventing recurrence of diabetic foot ulcers. Foot and Ankle Clinics N Am 11:735-743, 2006. Dotson, P. Efficacious Treatment of Diabetic Foot Ulceration with Total Contact Casting: Coding for Procedure and Product. Today s Wound Clinic, 12/18/12 Synder R, Hanft J. Diabetic Foot Ulcers Effects on Quality of Life, Costs, and Mortality and the Role of Stand Wound Care and Advanced-Care Therapies in Healing: A Review. Ostomy Wound Management 2009: 28-38. Sheehan P, Jones P, Caselli A, Giurini JM, Veves A. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Diabetes Care 2003;26:1879 82. Snyder RJ, et al. The Management of Diabetic Foot Ulcers through Optimal Offloading. Building Consensus Guidelines and Practical Recommendations to Improve Outcomes. Data from the US Wound Registry. Advances in Skin & Wound Care. July 2014

Niknejad H, Peirovi H, Jorjani M, et al. Properties of the amniotic membrane for potential use in tissue engineering. Eur Cells Mater. 2008; 15: 88-99. Koizumi NJ, Inatomi TJ, Sotozono CJ, et al. Growth factor mrna and protein in preserved human amniotic membrane. Curr Eye Res. 2000; 20:173 177. Mamede AC, Carvalho MJ, Abrantes AM, et al. Amniotic membrane: from structure and functions to clinical applications. Cell and Tiss Res. 2012; 349: 447-458. Cooke M, Tan EK, Mandrycky C, et al. Comparison of cryopreserved amniotic membrane and umbilical cord tissue with dehydrated amniotic membrane/chorion tissue. J Wound Care. 2014; 23(10): 465-474. Batsali AK, Kastrinaki MC, Papadaki HA, et al. Mesenchymal stem cells derived from Wharton s jelly of the umbilical cord: biological properties and emerging clinical applications. Curr Stem Cell Res & Ther. 2013; 8(2): 144-155. Lu LL, Liu YJ, Yang SG, et al. Isolation and characterization of human umbilical cord mesenchymal stem cells with hematopoiesis-supportive function and other potentials. Haematologica. 2006; 91: 1017-1026. http://www.enluxtrawoundcare.com http://www.osiris.com/

Baldursson, B. T. et al. Healing Rate and Autoimmune Safety of Full-Thickness Wounds Treated With Fish Skin Acellular Dermal Matrix Versus Porcine Small-Intestine Submucosa A Noninferiority Study. Int. J. Low. Extrem. Wounds 14, 37 43 (2015). Yang, C. K., Thais, O. P. & Lantis II, J. C. A Prospective, Postmarket, Compassionate Clinical Evaluation of a Novel Acellular Fish-skin Graft Which Contains Omega-3 Fatty Acids for the Closure of Hard-to-heal Lower Extremity Chronic Ulcers. Wounds Compend. Clin. Res. Pract. 28, (2016). Trinh, T. T., Dünschede, F., Vahl, C.-F. & Dorweiler, B. Marine Omega3 wound matrix for the treatment of complicated wounds: Experiences associated with amputations in the lower limb in diabetic patients. Phlebologie 45, 93 98 (2016). Magnusson, S. Retrospective Cost Effectiveness Analysis of 27 Hard to Heal Wounds. (2016). Magnusson, S. 87% of Wounds Either Improved or Healed after 4 weeks of Treatment with Acellular Fish Skin Graft: A Retrospective Study on 68 Wounds. (2016). Magnússon, S. et al. Affrumað roð: Eðliseiginleikar sem styðja vefjaviðgerð. Læknablaðið 2015, 567 573 (2015). Magnusson, S. Fish Skin Supports 3D Cell Ingrowth of Adipose Derived Mesenchymal Stem Cells for 21 days in vitro. (2016). Kerecis Product Instructions for Use

What s New in Wound Care? Meet Our Fantastic Four Nadia Din, DPM Kadin Foot & Ankle Center Medford, NJ