Use of Kerecis Omega 3 Fatty Acid Fish-skin Graft in Traumatic

WoundsWINDY COLE, DPMADJUNCT PROFESSOR AND DIRECTOR OF WOUND CARE RESEARCH KSUCPMMEDICAL DIRECTOR, WOUND CENTER, UH AHUJA HOSPITAL

Goals“The primary goal of wound care

is not the technical repair of the wound; it is providing optimal conditions for the natural reparative processes of the wound to proceed”

Goals It is important to recognize the intrinsic and extrinsic

factors that may impede wound healing or promote infection

Mechanism of injuryTime of injury or length wound presentEnvironment in which wound occurred

(contaminants or foreign bodies)Patient’s systemic medical conditions

Wound Healing Complex process involving activation and

synchronization of intracellular, intercellular, and extracellular elements including

Coagulation InflammationDeposition of collagenGranulationEpithelializationAnd remodeling

Wound Healing Divided into several continuous and overlapping processes:

Wound Healing The desirable final outcome of healing would be

the formation of tissue with similar structure and function as intact skin

Regeneration of such tissue is uncommon

Wound healing often results in structurally and functionally satisfactory tissue, but not identical tissue

Wound Healing Disruptions such as tissue loss, inadequate blood flow,

and comorbid disease states such as diabetes can cause wound healing to stall.

There are many strategies applied to the treatment of chronic wounds

Over the past 2 decades advancements in clinical understanding of the pathophysiology of wound healing has given rise to innovations in treatment

73+ Currently listed CTPs by Anthem Blue CrossAlloDerm Regenerative Tissue Matrix

AlloSkin

Apligraf

Dermagraft

EpiFix, sheet or membrane form

Integra Bilayer Matrix Wound Dressing

OrCel

TheraSkin

TransCyte

Affinity™

AlloDerm® RTM Ready to Use

AlloMax™

AlloMend™

Allopatch HD™

AlloSkin RT™

AlloWrap®

AlloWrap™ Dry

AlloWrap™ DS

Alphaplex™ with MariGen Omega3™

AmnioBand (see Guardian)

AmnioCare®

AmnioClear®

AmnioExcel™

AmnioFix™

AmnioGraft®

Amniomatrix™

AmnioMTM™

Avaulta Plus™

AxoGuard® nerve connector

AxoGuard® nerve protector

Belladerm®

Biobrane®

BioDDryFlex® Resorbable BioDExCel™

BioDfactor™

BioDfence™

BioDOptix™

BioFiber™

BioVance®

CellerateRX®

CG CryoDerm™

CLARIX™ 100 Quick-Peel

Wound Matrix

CLARIX™ 1k

CLARIX™ FLO

CollaFix™

CollaGUARD®

Collamend™

CollaSorb™

CollaWound™

Collexa®

Conexa™

DermaSpan™Dermavest™Dermavest 2™DressSkin™Duraform™Duragen™ PlusDuragen® XSDuraMatrix™Durepair® Regeneration MatrixEndobon® Xenograft GranulesEndoform™ENDURAgen™Epicel®EpiDex®EpiFix™, injectable formExcellagen®E-Z Derm™FlexHD®FloGraft™FortaDerm™ Wound DressingFortiva™ Porcine DermisGammagraft™GORE BIO-A® Fistula PlugGrafix® COREGrafix® PRIMEGraftJacket™Graftjacket™ Xpress injectableGuardian (see AmnioBand)HA Absorbent Wound DressingHelicollhMatrix®Hyalomatrix®Inforce®Integra™ Matrix Wound DressingIntegra® Dermal Reg. temp.InteguPly™Jaloskin®LiquidGen™MariGen Omega3Matriderm®Matristem®Matrix HD™Medeor™MediHoney®Mediskin®

Memoderm™Menaflex™ Collagen Meniscus ImplantMeso BioMatrix™Neoform Dermis™NEOX® 100 Quick-Peel Wound MatrixNEOX® 1k Wound MatrixNEOX® FLONeuragen®NeuraWrap™Neuroflex™NeuroMatrix™NeuroMend™NuCel®NuShield®Oasis™OrthADAPT™OsseoGuard®Ovation®Pelvicol®Pelvisoft®Peri-Guard® Repair PatchPeri-Strips Dry®Permacol™Phasix Mesh™Preclude® Dura SubstitutePriMatrix™Promogran™PTFE feltPuracol®Puros® DermisRepliform®Repriza™Restore® Orthobiologic Soft Tissue ImplantRevitalon™Seamguard®SERI® Surgical ScaffoldSIS Wound Dressing IISportMatrixSportMesh™

SS Matrix™Stimulen™ CollagenStrataGraft®Strattice™Suprathel®SurgiMend®Surgisis® (including Surgisis® AFP™ Anal Fistula Plug, Surgisis® Gold™ Hernia Repair Grafts, and Surgisis® Biodesign™)Talymed™TenoGlide™TenSIX™TheraForm™ Standard/SheetTissueMend®Tornier® BioFiberAbsorbable Biological ScaffoldTranzGraft®Tutomesh™ Fenestrated Bovine PericardiumTutopatch™ Bovine PericardiumUnite™Vascu-Guard®Veritas® Collagen MatrixXCM Biologic™Xelma®XenMatrix™XenMatrix™ Surgical Graft

XenoSure® BiologX-RepairXwrap™ (Hydro, DRY, and ECM)

Beware of choosing CTPs based on who bought the lunch for your clinic

Kerecis Omega 3 Fatty Acid Fish Skin Graft

Omega 3 Fatty Acids in Wound Healing

Kerecis is an acellular intact fish-skin graft that contains proteins, lipids (omega 3), and other naturally occurring structural elements

Kerecis has many bioactive properties due to the naturally occurring lipid content and preservation of native structure

Kerecis has been shown to recruit human-adipose stem-cell growth

The Omega 3 fatty acid gives rise to lipid mediators that help to resolve the chronic inflammatory state**

Magnusson S, Baldursson BT, Kjartansson H, et al. Decellularized fish skin: characteristics that support tissue repair. Laeknabladid. 2015:101. 567-73

Omega 3 Fatty Acids in Wound Healing

In the human body, Omega 3 fatty acids are a precursor to signaling molecules

These signaling molecules are important for many reasons Re-establishing homeostasis Host defense against bacteria Modulation of pain Tissue remodeling Anti-inflammatory properties

Omega 3 Fatty Acids in Wound Healing

Cells involved in the inflammatory response are typically rich in fatty acids

These molecules give rise to newly discovered resolvinsthat are anti-inflammatory and inflammation resolving

Studies have shown that changing the fatty acid composition of cells involved with the inflammatory response can influence their function

Serhan CN. Pro-resolving lipid mediators are leads for resolution physiology. Nature. 2014:510(7503):92-101

Pain Pathway

Omega 3 Fatty Acids in Pain Management

Neuropathic pain is caused by a lesion of the peripheral or central nervous system.

Most commonly trauma, inflammation, transection, nerve compression, ischemia or metabolic injuries are the cause

Damaged neurons display a sustained level of excitability

Omega 3 Fatty Acids in Pain Management

Omega 3 fatty acid are phospholipid components of cell membranes

Introduction of Omega 3 FAs in cases of traumatic or chronic wounds can thus reverse nerve cell damage and decrease excitability, thus decreasing pain.

Ko G, Arseneau L,Nowacki N, et al. Omega 3 Fatty Acids and Neuropathic Pain. Practical Pain Management. 2017:8(7):1-5.

Kerecis Omega 3 FA Fish Skin Graft in Trauma Wounds

Case 1 73 yo male patient sustained a fall

on the ice

Patient was on Xarelto for A-fib

Suffered from a large, painful hematoma of the entire lateral calf

Patient was taken into OR and had an I&D of hematoma using the Misonix SonicOne OR

A Cleanse Choice Infusion VAC system was used post-op

Patient was transitioned home with NPWT for 2 weeks

Pain level was 10++

Case 1

**After just one Kerecis application, patient’s pain level dropped to 4

Case 1

Case 1

**Patient’s pain level is now at 1

Case 1

Case 1

Case 1

Case 2 72 yo female with a

history of a ‘scratch’ on the back of her leg developed severe necrotizing fasciitis

She was taken to the OR where an aggressive debridement of the contaminated tissues was performed.

Case 2She subsequently

underwent multiple split-thickness skin grafts to close the wounds of the lower leg

Case 2

Contralateral thigh STSG sites

Case 2 After multiple split-thickness skin

grafts an area around the right medial ankle remained unhealed

Plastic surgeon did not recommend another STSG due to the amount of tissue already taken from patients thigh.

She came to me to see if Kerecis was an option for her.

Patient had a pain score of 8

Case 2 Results after just one

Kerecis graft to the area

Evidence of bridging and new epithelial tissue islands present

Pain level down to 2

Case 2

Case 3 79 yo male presents with

a necrotic ulcer of the posterior lower leg after an injury from his wheel chair

ABIs were good at 0.98

No signs of infection noted

Patient related a pain scale of 10 upon evaluation

Case 3 Patient presentation after

surgical debridement with Misonix SonicOne OR to remove devitalized and necrotic tissue.

After achieving a healthy granulation tissue base Kerecis graft was applied

Case 3

Case 4 68 yo female seen for lower leg

ulcer following a scratch from her care-giver’s ring while putting on her compression stockings

Wound continued to get worse over time and was fairly deep

Patient related a pain scale of 10 upon first presentation

Case 4

Case 4 After 2 applications of

Kerecis the patient’s pain scale was at a 3

After 6 weeks of Kerecis therapy the wound went on to complete closure

Case 5 66 yo female with history

of large dog scratch to the lower leg. Pain level was a 9

Wound exhibits a moderate amount of slough and devitalized tissue at the base

There is undermining from 9:00 to 1:00 with deep tracking at 3:00 that measures 4.2 cm deep

Case 5 Patient was initially treated with

2 weeks of negative pressure wound therapy and serial debridements

Once the majority of the wound base was beefy and granular Kerecis was applied

The wound still had an area of tracking that measured 1.1 cm in depth

Case 5

Case 5 Wound appearance after

one month

Beefy, red granular base

New evidence of epithelial tissue around wound edges

Less depth to lateral margin at 0.4 cm

Pain scale is now a 2

Case 5

Case 6 73 yo male presents with

injury of dorsal shin from an injury on a dish washer door

Patient had been putting Neosporin on the area

Pain scale was 8

Case 6 After 2 weeks

treatment with Kerecisthe wound is closing down well

No complications noted

Pain scale is now a zero

Case 6

Patient healed in 5 weeks.

Case 7 62 yo male S/P TMA

Large defect still present laterally due to removal of necrotic and devitalized tissue

Patient was placed on NPWT for 3 weeks

Case 7 The majority of the

amputation site healed well , but the remaining lateral aspect of the stump was recalcitrant to standard therapy

Began Kerecis on this visit

Case 7

Patient healed after only 2 Kerecis applications

In Conclusion Studies on Kerecis show that the Omega 3 FA fish-skin graft

harbors many bioactive properties

Kerecis recruits human adipose stem cell ingrowth which can aid in decreasing inflammation

Kerecis has a similar collagen architecture compared to human dermis

Kerecis has been shown to decrease pain symptoms do to hyper-excited nerve fibers