Yang CK, Polanco TO, Lantis JC 2nd, et al.
Wounds : a compendium of clinical research and practice. Date of publication 2016 Apr 1;volume 28(4):112-8.
1. Wounds. 2016 Apr;28(4):112-8.
A Prospective, Postmarket, Compassionate Clinical Evaluation of a Novel
Acellular Fish-skin Graft Which Contains Omega-3 Fatty Acids for the Closure of
Hard-to-heal Lower Extremity Chronic Ulcers.
Yang CK, Polanco TO, Lantis JC 2nd.
INTRODUCTION: A novel piscine acellular fish-skin graft product has 510k
clearance on the US market. This product (Omega3, Kerecis, Isafjordur, Iceland)
is to be used similarly to extracellular matrices (ECMs) on the market (eg,
bovine and porcine) except that it contains fats, including omega-3
polyunsaturated fatty acids that have been associated with anti-inflammatory
properties in many studies. While many current ECMs are effective on open
wounds, studies have largely excluded application to hard-to-heal ulcers. To
test this product in a real-world environment, the authors chose to look
specifically at hard-to-heal ulcers based on previously defined wound and
patient factors.
METHODS: The primary objective was to assess the percentage of wound closure
area from baseline after 5 weekly fish-skin graft applications in 18 patients
with at least 1 "hard-to-heal" criteria. Patients underwent application of the
fish skin for 5 sequential weeks, followed by 3 weeks of standard of care. Wound
area, skin assessments, and pain were assessed weekly.
RESULTS: A 40% decrease in wound surface area (P < 0.05) and a 48% decrease in
wound depth was seen with 5 weekly applications of the fish-skin graft and
secondary dressing (P < 0.05). Complete closure was seen in 3 of 18 patients by
the end of the study phase.
CONCLUSION: This fish-skin product appears to provide promise as an effective
wound closing adjunctive ECM. This is true when used in this compassionate
setting, where many other products fail. This study lacks a control arm and an
aggressive application schedule, but the investigators believe it represents
real-world practice.
PMID: 27071138 [Indexed for MEDLINE]
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