GUIDES

What Is the Evidence?

Decellularized Fish Skin Technology: Burns Kerecis® GraftGuide™

Kerecis® Omega3 has had numerous trials supporting its efficacy in healing rates. Decellularized fish skin technology also has significant positive supporting evidence in the healing and wound management of burns.

Efficacy

■ 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 4,6

■ 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 4,5

■ In a systematic review on the use of decellularized fish skin technology in burn wound management, Luze et al. write that the use of this technology may represent an effective, low-cost alternative for the treatment of deep partial thickness burns and superficial partial-thickness burns, claiming the evidence indicates accelerated wound healing, reduction of pain and necessary dressing changes as well as improved long-term outcomes 10

Quality of Wound Healing

■ Compared to mammalian-based skin substitutes, Kerecis® Omega3 offers improved economics and clinical performance, as well as reduced disease transfer risk 4,5

■ Mammalian tissue carries the risk of disease transmission to humans. This is not a risk with Kerecis® Omega3 4,5

■ Kerecis® Omega3 fish skin contains lipids and proteins that, in a concentrated form, help the body regenerate damaged tissue 4,5

■ Kerecis® GraftGuide™ Mano allows patients to begin physical therapy after application, meaning that healing can be faster and loss of hand motion is less likely 3,6,7

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 4,5

“I have seen first-hand the benefits of using fish skin grafts for burns, and GraftGuide Mano takes it to the next level with its innovative design. I am excited to incorporate it into my practice and see the positive impact it can have on my patients.”

“GraftGuide Micro has exceeded my expectations in terms of its handling properties.”

Lt. Col Steven Jeffery, Burn and plastic surgeon, Royal Army Medical Corps (RAMC); Professor, Birmingham City University, UK 7

“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.” Dorweiler, et al. 2018 14

Key Points

■ Kerecis® GraftGuide™ is a product line designed to address the problem of burn healing and management

■ Kerecis® GraftGuide™ Mano is designed for burns on the hand

■ Kerecis® GraftGuide™ Micro is designed for use in burns with uneven surfaces and in deeper spaces

■ No cultural or religious barriers to clinician/ patient acceptance

■ Non allergenic and bio-compatible

■ No known risk of disease transfer

■ Improved infection control

References

1. Magnusson, S. et al. Decellularized fish skin: characteristics that support tissue repair. Laeknabladid 101, 567–573 (2015).

2. 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 non-inferiority study. Int. J. Low. Extrem. Wounds 14, (2015).

3. Kerecis® GraftGuide™ Fish skin application for burns. Kerecis®, 2023. [Internet]. https://www.kerecis.com/omega3-burn/ [accessed 20/03/2023].

4. Kerecis® Fish-Skin Technology. Kerecis®, 2023. [Internet]. https://www.kerecis.com/omega3-fishskin/ [accessed 20/03/2023].

5. Masterclass Guide: Kerecis® Omega3. Wound Masterclass. Volume 1. No 2. Sept 2022.

6. Kerecis® introduces GraftGuide™ Mano and GraftGuide™ Micro. Medical Device Network, 2023. [Internet]. https://www.medicaldevice-network.com/news/kerecis-graftguide-mano-micro/ [Accessed 20/03/2023].

7. Kerecis Announces New Fish-Skin Burn Products. Business Wire, 2023. [Internet]. https://www.businesswire.com/news/home/20230120005442/en/Kerecis-Announces-New-Fish-Skin-Burn-Products/ [Accessed 20/03/2023].

8. Kerecis® Omega3 GraftGuide™ Instructions for use. [Internet, PDF]. Available from: https://www.kerecis.com/wp-content/uploads/2023/01/KM-21-0111_v3-IFU-Kerecis-Omega3-GraftGuide-US-EO-US.pdf [accessed 20/03/2023].

9. Lullove EJ, Liden B, Winters C, McEneaney P, Raphael A, Lantis Ii JC. A Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Effect of Omega-3-Rich Fish Skin in the Treatment of Chronic, Nonresponsive Diabetic Foot Ulcers. Wounds. 2021 Jul;33(7):169-177. doi: 10.25270/wnds/2021.169177. Epub 2021 Apr 14. PMID: 33872197.

10. Luze H, Nischwitz SP, Smolle C, Zrim R, Kamolz LP. The Use of Acellular Fish Skin Grafts in Burn Wound Management-A Systematic Review. Medicina (Kaunas). 2022 Jul 9;58(7):912. doi: 10.3390/medicina58070912. PMID: 35888631; PMCID: PMC9323726.

10. Huang, R., Chan, A., Wu, S. The Impact of HbA1c Levels on Diabetic Foot Ulcers Using Fish Skin Grafts. Wound Masterclass. Volume 1. No 2. Sept 2022.

11. Statkus, R. P., Darji, D., McEneaney, P. A., Rundell, J. D. Surgical Applications of Intact and Fragmented Fish Skin Grafts and NPWT for Lower Extremity Wounds: A Case Report. Wound Masterclass. Volume 1. No 2. Sept 2022.

12. Romberg, M. S. Hidradenitis Suppurativa: A Guide to Surgical Management With Omega3-Rich Fish Skin Grafts. Wound Masterclass. Volume 1. No 2. Sept 2022.

13. Wahab, N. The Application of Omega3 Fish Skin Graft in Nutritional Skin Failure Syndrome: Two Case Studies. Wound Masterclass. Volume 1. No 2. Sept 2022.

14. Dorweiler B, Trinh TT, Dünschede F, Vahl CF, Debus ES, Storck M, Diener H. The marine Omega3 wound matrix for treatment of complicated wounds: A multicenter experience report. Gefasschirurgie. 2018;23(Suppl 2):46-55. doi: 10.1007/s00772-018-0428-2. Epub 2018 Aug 1. PMID: 30147244; PMCID: PMC6096721.

15. 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.

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

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

18. 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.

19. 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.

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

21. 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.

22. 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.