What are the best studies showing the effectiveness of Kerecis (Omega-3 rich fish skin graft) in wound healing?

Effectiveness of Kerecis Fish Skin Grafts in Wound Healing

Based on the available evidence, Kerecis fish skin grafts show promising results in wound healing, particularly for diabetic foot ulcers, but there is insufficient high-quality evidence to recommend their routine use over standard care in all wound types.

Evidence for Kerecis Fish Skin Grafts

Clinical Effectiveness

• A 2021 multicenter, blinded, randomized controlled trial demonstrated that Kerecis fish skin grafts resulted in significantly higher complete wound closure rates (67%) compared to standard of care (32%) at 12 weeks in treatment-resistant diabetic foot ulcers (P=0.0152) 1
• In a 2019 prospective evaluation, diabetic foot wounds less than three months duration showed median percentage wound area reduction of over 84.9% at six weeks when treated with Kerecis Omega3 fish skin grafts 2
• A 2016 prospective study on hard-to-heal lower extremity chronic ulcers showed a 40% decrease in wound surface area (P<0.05) and a 48% decrease in wound depth (P<0.05) after 5 weekly applications of fish skin grafts 3

Mechanism of Action and Properties

• Kerecis fish skin grafts contain omega-3 polyunsaturated fatty acids which have been associated with anti-inflammatory properties 3
• A 2022 comparative study found that acellular fish skin (Kerecis®) demonstrated faster healing times (10.7 ± 1.5 days) compared to bovine collagen skin grafts (13.1 ± 1.4 days) in split-thickness donor sites for burn patients 4
• The unique biophysical structure and bioactive components of acellular fish skin may contribute to its wound healing properties 4

Specific Clinical Applications

• Fish skin grafts have shown potential in treating extensive wounds after necrotizing fasciitis, with observed benefits including promotion of wound granulation and pain relief 5
• Particularly effective in wounds less than three months duration, suggesting potential benefit when used early in the healing process 2

Limitations and Considerations

Guideline Recommendations

• The International Working Group on the Diabetic Foot (IWGDF) does not specifically recommend fish skin grafts in their guidelines 6
• IWGDF generally recommends against routine use of skin substitutes for diabetic foot ulcers, stating: "Do not select agents reported to improve wound healing by altering the biology of the wound, including growth factors, bioengineered skin products and gases, in preference to accepted standards of good quality care" 6
• The 2023 IWGDF update suggests not using acellular skin substitute products as routine adjunct therapy for wound healing in diabetic foot ulcers (Conditional; Low evidence) 6

Evidence Quality Concerns

• Most studies on skin substitutes, including fish skin grafts, have methodological limitations such as non-blinding, high dropout rates, and per-protocol analyses rather than intention-to-treat analyses 6
• The IWGDF notes that for many biological products, "firm data are required for both its effectiveness and its cost-effectiveness before it is considered for use in routine care" 6
• Limited high-quality evidence comparing fish skin grafts to other established treatments for various wound types 6

Clinical Decision Algorithm

1. For diabetic foot ulcers:

   • Consider fish skin grafts for treatment-resistant diabetic foot ulcers that have failed to respond to standard of care for at least 2 weeks 1
   • Most beneficial for wounds less than 3 months duration 2

2. For post-surgical wounds:

   • May be considered as an adjunctive therapy, though evidence is limited 2
   • Particularly promising for split-thickness donor sites in burn patients 4

3. For complex wounds with exposed structures:

   • Consider in cases with exposed bone or tendons, such as after necrotizing fasciitis, where promoting granulation is critical 5

4. Application protocol:

   • Weekly application for 5-12 weeks has shown benefit in clinical studies 1, 3
   • Should be applied after appropriate debridement 1

Conclusion

While Kerecis fish skin grafts show promising results in several studies, particularly for diabetic foot ulcers, current guidelines do not yet support their routine use over standard care. The strongest evidence comes from the 2021 multicenter RCT showing significantly better healing rates compared to standard care in treatment-resistant diabetic foot ulcers. Consider using Kerecis as an adjunctive therapy in cases that have failed to respond to standard care, particularly for wounds less than 3 months duration.