Healing Rate and Autoimmune Safety of Full-Thickness Wounds Treated With Fish Skin Acellular Dermal Matrix Versus Porcine Small-Intestine Submucosa

Abstract

A novel product, the fish skin acellular dermal matrix (ADM) has recently been introduced into the family of biological materials for the treatment of wounds. Hitherto, these products have been produced from the organs of livestock. A noninferiority test was used to compare the effect of fish skin ADM against porcine small-intestine submucosa extracellular matrix in the healing of 162 full-thickness 4-mm wounds on the forearm of 81 volunteers. The fish skin product was noninferior at the primary end point, healing at 28 days. Furthermore, the wounds treated with fish skin acellular matrix healed significantly faster. These results might give the fish skin ADM an advantage because of its environmental neutrality when compared with livestock-derived products. The study results on these acute full-thickness wounds might apply for diabetic foot ulcers and other chronic full-thickness wounds, and the shorter healing time for the fish skin-treated group could influence treatment decisions. To test the autoimmune reactivity of the fish skin, the participants were tested with the following ELISA (enzyme-linked immunosorbent assay) tests: RF, ANA, ENA, anti ds-DNA, ANCA, anti-CCP, and anticollagen I and II. These showed no reactivity. The results demonstrate the claims of safety and efficacy of fish skin ADM for wound care.

Marine Omega3 wound matrix for the treatment of complicated wounds

“…Those initial results are corroborated by another study where the omega-3 wound patch was used in a series of 81 volunteers with forearm wounds. Here, the fish skin product was noninferior at the primary end point of healing at 28 days and the wounds treated with fish skin acellular matrix healed significantly faster than the control group (intestinal submucosa) (11).…”

<p>Fish skin acellular dermal matrix: potential in the treatment of chronic wounds</p>

“…There was significantly (P=0.041) faster wound closure in the AFS group ( Figure 2), and no autoimmune reaction, as evidenced by ELISA tests on rheumatoid factor, antinuclear antibodies, antinuclear cytoplasmic antibody, aetractable nuclear antibody, anti-double sided-DNA, anti-cyclic citrullinated peptide, and anticollagen I and II. 12 These positive data allowed the entry of the AFS to the US market through the 510 (k) pathway.…”

“…Most ECMs demonstrate similarities to porcine submucosa. In total, there have been two blinded randomized controlled clinical trials showing that treatment of acute forearm wounds with AFS allows for significantly faster wound closure than porcine small intestine submucosa (SIS)-derived matrices 12 and dehydrated human amnion/chorion membrane (dHACM). 13 In 2014, the manufacturer of AFS needed to show the FDA that AFS was similar or superior to a presently commercially available ECM product in its ability to close wounds.…”

Wound healing grafts: Omega‐3 fatty acid lipid content differentiates the lipid profiles of acellular Atlantic cod skin from traditional dermal substitutes

“…The thickness of fish skin may contribute to its enhanced bacterial barrier properties when compared with thinner biological grafting materials, derived from the lining of internal organs. Perhaps most importantly, cold water fish is known to be rich in omega‐3 polyunsaturated fatty acids (PUFAs; Cholewski, Tomczykowa, & Tomczyk, ; Osman, Jaswir, Khaza'ai, & Hashim, ), and this may contribute to its properties of reducing local inflammation and promoting angiogenesis (Magnusson et al, ), thus supporting wound healing with concomitant pain relief and reduced scarring (Baldursson et al, ; Dorweiler et al, ).…”