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Baldursson BT, Kjartansson H, Konrádsdóttir F, Gudnason P, Sigurjonsson GF, Lund SH, et al.
The international journal of lower extremity wounds. Date of publication 2015 Mar 1;volume 14(1):37-43.
1. Int J Low Extrem Wounds. 2015 Mar;14(1):37-43. doi: 10.1177/1534734615573661. Epub 2015 Mar 9. Healing rate and autoimmune safety of full-thickness wounds treated with fish skin acellular dermal matrix versus porcine small-intestine submucosa: a noninferiority study. Baldursson BT(1), Kjartansson H(2), Konrádsdóttir F(3), Gudnason P(4), Sigurjonsson GF(4), Lund SH(5). Author information: (1)National University Hospital of Iceland, Reykjavik, Iceland Kerecis Ltd, Isafjordur, Iceland baldurb@landspitali.is. (2)National University Hospital of Iceland, Reykjavik, Iceland Kerecis Ltd, Isafjordur, Iceland. (3)Kerecis Ltd, Isafjordur, Iceland University of Iceland, Reykjavik, Iceland Agricultural University of Iceland, Reykjavik, Iceland. (4)Kerecis Ltd, Isafjordur, Iceland. (5)University of Iceland, Reykjavik, Iceland. 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. © The Author(s) 2015. DOI: 10.1177/1534734615573661 PMID: 25759413 [Indexed for MEDLINE]
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Cellular and/or Tissue Based Products