title: Healing rate and autoimmune safety of full-thickness wounds treated with fish skin acellular dermal matrix versus porcine small-intestine submucosa: a noninferiority study.
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.
authors.affiliation: National University Hospital of Iceland, Reykjavik, Iceland Kerecis Ltd, Isafjordur, Iceland baldurb@landspitali.is.
authors.forename: Baldur Tumi
authors.initials: BT
authors.lastname: Baldursson
authors.affiliation: National University Hospital of Iceland, Reykjavik, Iceland Kerecis Ltd, Isafjordur, Iceland.
authors.forename: Hilmar
authors.initials: H
authors.lastname: Kjartansson
authors.affiliation: Kerecis Ltd, Isafjordur, Iceland University of Iceland, Reykjavik, Iceland Agricultural University of Iceland, Reykjavik, Iceland.
authors.forename: Fífa
authors.initials: F
authors.lastname: Konrádsdóttir
authors.affiliation: Kerecis Ltd, Isafjordur, Iceland.
authors.forename: Palmar
authors.initials: P
authors.lastname: Gudnason
authors.affiliation: Kerecis Ltd, Isafjordur, Iceland.
authors.forename: Gudmundur F
authors.initials: GF
authors.lastname: Sigurjonsson
authors.affiliation: University of Iceland, Reykjavik, Iceland.
authors.forename: Sigrún Helga
authors.initials: SH
authors.lastname: Lund
mesh_terms: D062088:Acellular Dermis; D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D001323:Autoantibodies / Q000097:blood; D015551:Autoimmunity; D004311:Double-Blind Method; D005260:Female; D005399:Fishes; D005500:Follow-Up Studies; D006801:Humans; D007421:Intestine, Small / Q000637:transplantation*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012867:Skin / Q000293:injuries; D016038:Skin Transplantation / Q000379:methods*; D017768:Skin, Artificial; D013552:Swine; D058106:Wound Closure Techniques; D014945:Wound Healing / Q000276:immunology*; D014947:Wounds and Injuries / Q000276:immunology / Q000628:therapy*; D055815:Young Adult
chemical_list: D001323:Autoantibodies
keywords: Kerecis Omega3; MariGen; antigenicity; oasis; omega-3 polyunsaturated fatty acids; punch biopsy