Abstract
BACKGROUND: Achieving stable closure of complex or contaminated abdominal wall incisions remains challenging. This study aimed to characterize the stage of innovation for biological mesh devices used during complex abdominal wall reconstruction and to evaluate the quality of current evidence. METHODS: A systematic review was performed of published and ongoing studies between January 2000 and September 2017. Eligible studies were those where a biological mesh was used to support fascial closure, either prophylactically after midline laparotomy, or for reinforcement after repair of incisional hernia with midline incision. The primary outcome measure was the IDEAL framework stage of innovation. The key secondary outcome measure was the GRADE criteria for study quality. RESULTS: Thirty-five studies including 2681 patients were included. Four studies considered mesh prophylaxis, 23 considered hernia repair, and eight reported on both. There was one published randomized trial (IDEAL stage 3), none of which was of high quality; the others were non-randomized studies (IDEAL stage 2a). A detailed description of surgical technique was provided in most studies (27 of 35); however, no study reported outcomes according to the European Hernia Society consensus statement and only two described quality control of surgical technique during the study. From 21 ongoing randomized trials and observational studies, 11 considered repair of incisional hernia and 10 considered prophylaxis (seven in elective settings). CONCLUSION: The evidence base for biological mesh is limited, and better reporting and quality control of surgical techniques are needed. Although results of ongoing trials over the next decade will improve the evidence base, further study is required in the emergency and contaminated settings.