Masterclass Guides: Decellularized Fish Skin Technology: Burns

March - April 2023

Introduction

This is a Masterclass Guide to decellularized fish skin technology specifically designed to address the challenges of burn healing, providing a concise overview of these innovative new treatments; what they are, how to incorporate them into your practice and what evidence we have for them.

What Is Kerecis® GraftGuide™?

■ Decellularized intact fish skin specifically developed to address the challenges of burn healing and burn wound management. Intact fish skin is used to regenerate tissue on surgical, traumatic, and acute wounds 1-5

■ It contains lipids and proteins that (in a concerted manner), help the body to regenerate damaged tissue 3-5

■ 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 1-5

■ GraftGuide™ Mano (Figure 2a) is designed for burns on the hand; it covers the hand in such a way that the need for fixation and multiple grafts is reduced 3,6,7

■ GraftGuide™ Micro (Figure 2b) is the fragmented form of this technology, designed for use in burns with uneven surfaces and in deeper spaces 3,6,7

Decellularized Fish Skin Technology: Burns Kerecis® GraftGuide™

Keywords

■ Kerecis® GraftGuide™

■ Decellularized fish skin technology

■ Regenerative healing

■ Wound management

■ Natural intact fish skin

■ Wound

■ Wounds

■ Burns

Kerecis® GraftGuide™ Mano

Kerecis® GraftGuide™ Micro

1 When applying for the first time, debride the wound bed to obtain a fresh tissue surface by removing necrotic tissue or tangential excision

2 Irrigate to remove debris and exudates. Control bleeding after applying the fish skin graft

3 Remove product from the pouch using aseptic technique

4 Fit the product roughly to the size of the area to be covered. Prehydrate in sterile solution

5 Apply product directly into the wound. The product should not overlap the wound edges

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

7 To maintain direct device contact with wound bed/surface the device can be secured with steristrips, sutures, or staples

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

9 Inspect wound every two days. The duration between inspections may be extended up to seven days as the healing progresses

10 Insert a new product into the wound if the previously applied product has been absorbed and is no longer visible. Change the cover dressing as needed to maintain a moist, clean wound area 8

How Kerecis® GraftGuide™ Works: The Ten Point Guide

Figure 1: Kerecis® GraftGuide™ standard

Figure 2a:

Figure 2b:

Decellularized Fish Skin Technology: Burns

Kerecis® GraftGuide™

What Types of Wounds Are Suitable?

■ Partial and full thickness wounds

■ Trauma wounds

■ Surgical wounds (donor sites, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) 1-3

■ Burns

THERMAL BURN

Contraindications

■ Contraindicated in patients with a known allergy or other sensitivity to fish 3-5

Scope of Usage

22 year old male, thermal burn to the back.

The patient with a past medical history of hydronephrosis presented with a 19% total body surface area thermal burn.

The mechanism of the burn was bonfire-induced, with clothing set alight.

The patient presented to the burn center two days post initial injury having had an initial treatment with silver sulfadiazine cream. A single application of fish skin graft resulted in good secondary intention healing for the patient, without the need for an autograft.

3a, 3b: Initial presentation images.

3c: Day 2 pre-treatment images.

3d, 3e: Day 2 – post dermabrasion and fish skin graft application.

3f: Post-operative day 4.

3g, 3h: Post-operative day 15.

3i: Post-operative day 21.

SCALD BURN

Patient 3: 65 year old female, scald burn to the lower leg.

The patient had inflammatory arthritis and rheumatoid arthritis, chronic kidney disease stage 3, obesity and pulmonary valve dysfunction and concurrent small cell carcinoma stage IV and was undergoing chemotherapy.

The patient presented on day 10 post injury, with a 3% total body surface area scald burn, previous treatment was standard of care and Collagenase Santyl . Patient was discharged from the practice due to follow up limitations and chemotherapy treatments. During follow up (1 year after treatment), patient had improved pigment matching, skin was soft and pliable with no itching, and showed a full range of motion without limitation.

4a: Appearance of wound on day 10.

4b: Post debridement.

4c: Fish skin graft application.

4d: Post-operative day 8.

4e: Post-operative day 15.

4f: Post-operative day 25.

Figure 3

Figure 4

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.

Pre-meshed 2:1

fish-skin graft

Expands to cover wounds over 100 cm²

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

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