Masterclass Guides: Decellularized Fish Skin Technology Kerecis® Omega3

September - October 2022

Introduction

This Masterclass Guide is a concise overview aimed at exploring the use of acellular fish skin technology and how to incorporate this into your practice.

Decellularized Fish Skin Technology

Kerecis® Omega3

What Is Kerecis® Omega3?

■ Decellularized intact fish skin developed for the management of chronic wounds

■ FDA cleared graft, which is rich in polysaturated Omega3 fatty acids (EPA and DHA), which are known for their anti-inflammatory properties

■ It contains lipids and proteins that (in a concerted manner), help the body regenerate damaged tissue

■ Derived from decellularized Icelandic cod skin. Its protein composition closely resembles that of human skin and the porous microstructure provides a scaffold for efficient ingrowth of dermal cells and capillaries

■ Sheets contain fat, protein, elastin, glycans and other natural skin elements and are provided in different sizes

■ Applications include reconstructing skin in burns, chronic wounds, oral wounds, hernia repair, breast reconstruction, and dura mater reconstruction

Keywords

■ Kerecis® Omega3

■ Regenerative healing

■ Natural intact fish skin graft

■ Polysaturated omega3 fatty acid

■ Wound

■ Wounds

■ Complex wounds

■ Reconstruction

■ Dermal matrix

■ Wound repair

How to Use Kerecis® Omega3: The Ten Step Guide

1 Select the appropriate patient

2 Clean the wound bed by removing necrotic tissue to obtain a fresh tissue surface, can be applied to a lightly bleeding wound bed

3 Remove the product from the pouch using an aseptic technique

4 Fit the product roughly overlapping the area to be covered and prehydrate in a sterile saline solution

5 Apply product directly into the wound

6 Overlap product edges slightly to ensure coverage of entire wound. More than one product may be necessary for complete coverage.

7 Apply an appropriate secondary, non-adherent wound dressing to maintain a moist wound environment

8 Inspect wound every two days. Duration of inspection may be extended up to seven days as healing progresses

9 Insert new Kerecis® Omega3 product into the wound if the previously applied product has been absorbed and is no longer visible

10 Change the cover dressing as needed to maintain a moist, clean wound area

Figure 2: The Kerecis® Omega3 Fish Skin Graft

Figure 1: Icelandic Cod Fish

Decellularized Fish Skin Technology

Kerecis

® Omega3

What Types of Wounds Are Suitable? Contraindications

■ Diabetic ulcers

■ Chronic vascular ulcers

■ Venous ulcers

■ Trauma wounds (including abrasions, lacerations and skin tears)

■ Acute surgical wounds (including debridement, amputation and donor sites)

■ Surgical wounds (dehiscence or failed healing after surgery)

■ Imminent failure of split thickness skin graft

■ Post-injection necrosis

■ Contraindicated in patients with a known allergy or other sensitivity to fish

Points to Consider

■ Remove necrotic tissue under the graft prior to product application

■ Remove exudate and control bleeding before application

■ Do not reuse or re-sterilize

■ Discard unused portions of the product

■ Do not use after printed expiration date

■ Product is sterile if package is unopened and undamaged

■ Do not use device if package seal has been broken or if handling has caused damage or contamination

Figure 3: Microscopic view

Human derived graft

Kerecis® Omega3 Fish Skin Graft

Decellularized Fish Skin Technology

Kerecis® Omega3

What Is the Evidence?

Kerecis® Omega3 has had numerous trials supporting its efficacy in healing rates. A study regarding the use of Kerecis® Omega3 on diabetic foot ulcers (DFU) showed significantly higher healing rates compared to DFUs treated by fibrocol, a collagen-alginate dressing.

Efficacy Quality of Wound Healing

■ Other tissue transplant products that are based on tissues of human and porcine origin are not ideal substitutes because of the heavy processing needed to eliminate the risk of disease transmission. This harsh, anti-viral treatment removes most of the material’s natural components, making it too dissimilar to human skin.

Kerecis® Omega3 is not subject to this treatment, leaving a more naturally intact product

■ Kerecis® has demonstrated its proficiency in creating lipidcontaining tissue matrices from fish skin, and it has been shown that the material is safe, non-toxic and structurally sound

■ A recent publication of an RCT by Lullove et. al (2022) shows 106% more healed wounds at 12 weeks compared to Collagen-Algenate dressing, a statistically significant finding

■ Compared to mammalian-based skin substitutes, Kerecis® Omega3 offers improved economics and clinical performance, as well as reduced disease transfer risk

■ Mammalian tissue carries the risk of disease transmission to humans. This is not a risk with Kerecis® Omega3

■ Kerecis® Omega3 fish skin contains lipids and proteins that, in a concentrated form, help the body regenerate damaged tissue

Costs

■ Kerecis® is focused on developing medical device applications with a predicated high return on investment and a low to medium cost of development. The company focuses exclusively on tissue regeneration and maintenance, utilizing its core Omega3 fish skin technology.

“These results will help guide clinicians to make decisions that positively impact both their patients’ outcomes and treatment costs.”

“The standard of care for treating DFUs is constantly improving... We compared the fish skin to an advanced collagen-alginate dressing to represent current alternatives. We wanted to compare it to more than just a simple wet-to-dry gauze or other, older methods.”

"The Kerecis™ Omega3 Wound matrix is a decellularized skin matrix derived from fish skin and represents an innovative concept to achieve wound healing... in this study (it) represented an effective treatment option in 25 complicated wounds."

Decellularized Fish Skin Technology

Key Points

■ No cultural or religious barriers to clinician/ patient acceptance

■ Easier to use, with larger, thicker sheets (no need for multi-layer grafts)

■ Non allergenic and bio-compatible

■ No known risk of disease transfer

■ Improved infection control

■ Adjustable rate of absorption into the surrounding tissue

■ Statistically significant increase in healed DFUs at 12 weeks compared to Collagen-Algenate dressing

References

1. Harris WS, Mozaffarian D, Lefevre M, Toner CD, Colombo J, et al. Towards establishing dietary reference intakes for eicosapentaenoic and docosahexaenoic acids. J Nutr. 2009;139:804S-819S.

2. Feingold KR. Thematic review series: Skin lipids. The role of epidermal lipids in cutaneous Permeability barrier homeostasis. J Lipid Res. 2007;48:2531-2546.

3. Badylak SF, Freytes DO, Gilbert TW. Extracellular matrix as a biological scaffold material: Structure and function. Acta Biomater. 2009;5:1-13.

4. Reing JE, Zhang L, Myers-Irvin J, Cordero KE, Freytes DO, et al. Degradation products of extracellular matrix affect cell migration and proliferation. Tissue Eng Part A. 2009;15:605-614.

5. Lin CC, Ritch R, Lin SM, Ni MH, Chang YC, et al. A new fish-scale-derived scaffold for corneal regeneration. Eur Cell Mater. 2010;19:50-57.

6. Hawkes JW. The structure of fish skin. I. General Organization. Cell Tissue Res. 1974;149:147-158.

7. Le Guellec D, Morvan-Dubois G, Sire JY. Skin development in bony fish with particular emphasis on collagen deposition in the dermis of the zebrafish (Danio rerio). Int J Dev Biol. 2004;48:217-231.

8. Rakers S, Gebert M, Uppalapati S, Meyer W, Maderson P, et al. ‘Fish Matters’: the relevance of fish-skin biology to unvestigative dermatology. Exp Dermatol. 2010;19:313-324.

A novel solution for chronic wounds that are larger than 100cm2 and treated in the outpatient setting

Pre-meshed 2:1

fish-skin graft

Expands to cover wounds over 100 cm²

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