Acera Surgical has announced its first patient enrolment in a multicentre, head-to-head clinical study evaluating Restrata for the treatment of non-healing venous leg ulcers (VLUs). William Marston (University of North Carolina School of Medicine, Chapel Hill, USA) is the study’s lead investigator. The study will be the first level 1 clinical comparison between Restrata and a biologic skin substitute, according to a company press release.
Bradley P Abicht (Gundersen Health System, La Crosse, USA) commented: “Our team is excited to participate in this head-to-head, prospective clinical trial to further develop Restrata as a novel approach for difficult-to-treat VLUs. Our practice has been pleased with the outcomes of Restrata when used to treat very complex lower extremity wounds of varying aetiology.”
John Park (Nebraska Methodist Hospital in Omaha, USA) remarked: “I am very delighted to be part of this trial and to enrol our centre’s first patient as it will provide important evidence comparing the efficacy of Restrata versus a leading competitor for the treatment of VLUs. I applaud Acera Surgical for conducting this study since it is the first of its kind in a VLU population.”
The study is a prospective, randomised multicentre trial comparing wound closure between Restrata, the synthetic hybrid-scale fibre matrix, with a living cellular skin substitute in the treatment of VLUs. The primary outcome measurement of the trial will be the number of study participants with 100% epithelialisation (closure) of the wound within a 16-week period.
Nick Gallucci, Acera’s chief commercial officer, said: “Over the course of our short history, Acera Surgical has demonstrated our commitment to proving the benefits of synthetic wound healing through investment in high quality research. Today’s healthcare environment demands high-quality outcomes for patients while improving the efficacy of healthcare delivery. We are extremely excited about the response to Restrata we are getting from across the wound care spectrum, both physicians and administrators alike.”
