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Pignet et al. Plast Aesthet Res 2024;11:40  https://dx.doi.org/10.20517/2347-9264.2024.54  Page 11 of 14

               endpoints as epithelialization at the 28th day, erythema, pain, infection and price comparison of both
                              [11]
               treatment groups . Wounds treated with Kerecis® Omega3 Wound Matrix showed significantly shorter
               healing times (P = 0.0014) compared with dHACM-treated defects, with an expected healing time of 22 days
                                                                                                    [11]
               for 50% of defects treated with Kerecis® Omega3 Wound Matrix versus 24 days for dHACM . No
               significant difference was observed between both groups regarding adverse reactions. While Kerecis®
               Omega3 Wound Matrix required on average 1.6 applications per participant and dHACM 1.4 applications,
               a significant overall increase in the cost to treat was observed in the dHACM group compared to Kerecis®
                                                                [11]
               Omega3 Wound Matrix (P < 0.001), with 76% higher costs .
               Adverse events and safety of FSG
               No adverse events were observed across the included studies. No patient showed any reaction associated
               with the two different types of FSGs that were discussed here. This indicates a high safety level for patients.
               Moreover, there were no incidences of infection in wounds that were devoid of signs of infection prior to
               the application of the product.

               Conclusion
               FSGs seem to be a promising new tool in the field of burn care and complex trauma wounds, which have
               been shown to be beneficial for easy- and hard-to-heal wounds likewise [20,24,25] . Most studies on SPTB have
               been conducted with NTG, whereas Kerecis® Omega3 Wound Matrix was used in all studies on donor
               sites [15,19,23,24] . Despite the lack of comparability, both types of wounds can be considered easy-to-heal
               wounds, in which similar beneficial effects on pain control, re-epithelialization time, and the required
               number of dressing changes were achieved through both Kerecis® Omega3 Wound Matrix and NTG [15,18,24] .
               The reduced number of dressing changes, especially in large-scale burns, seems to be one of the main
               advantages of both types of acellular FSGs . However, in donor sites, careful cost-benefit considerations
                                                    [14]
               should be made when using a costly product such as Kerecis® Omega3 Wound Matrix. Unfortunately, no
               direct comparison between Kerecis® Omega3 Wound Matrix and NTG can be made due to the different
               indications, study designs, and different control products.


               In the context of deep dermal burns and complex trauma wounds, FSGs might allow for a step-down of the
               reconstructive ladder. Some authors were able to use Kerecis® Omega3 Wound Matrix on priorly debrided
               deep partial-thickness burns as an alternative to autografting with superior long-term results to
               autografts . Lima Júnior et al. showed in their RCT that in small-size deep partial-thickness burns,
                        [16]
               conservative treatment with NTG performed well in terms of re-epithelialization time, pain control, and the
               frequency of dressing changes . Kerecis® Omega3 Wound Matrix might also have beneficial impacts on the
                                        [14]
               healing outcomes in full-thickness burns . As the product seems to strongly promote new tissue
                                                     [25]
               formation , it can be used after deep excision and before grafting in order to minimize contour deficits .
                                                                                                       [25]
                        [11]
               The same applies to complex trauma wounds, where wound conditioning and new tissue formation to
               reliably cover and protect deeper structures could allow for less invasive reconstructive surgery . Most
                                                                                                   [20]
               studies on deep dermal burns and complex wounds were conducted with Kerecis® Omega3 Wound Matrix.
               Nevertheless, the question of which fish skin product to use is irrelevant in most cases, as only Kerecis®
               Omega3 Wound Matrix is FDA-approved and available worldwide. NTG seems to be a cost-effective
               alternative for countries that have direct access to the fish.

               However, again, among the available studies, there is a limited number of high-quality studies, such as
               RCTs. In order to generate a meaningful treatment algorithm and to make use of the full potential of the
               product, more high-quality studies are urgently needed.
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