“…Value begins with evidence-based medicine, and wound care is plagued by the paucity of well-designed, comparative clinical trials in welldefined patient cohorts. Despite a few prominent exceptions, most of the products for skin wounds lack adequate data on clinical outcomes, 105 which may be partly due to their approval along the device 510K regulatory pathway that does not require randomized controlled trials comparing them with standard of care, as well as the historical ability of products to achieve market access without such data. Moreover, even randomized studies in wound healing tend to be relatively small and lack an attempt at blinding, such as raters who are unaware of group assignment.…”