Systematic review of the stage of innovation of biological mesh for complex or contaminated abdominal wall closure

Abstract

BackgroundAchieving 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.MethodsA 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.ResultsThirty‐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).ConclusionThe 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.

Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial

“…9 Some retrospective case-series have suggested that biological meshes can be safely used in complex and contaminated settings; 5,9 high quality or randomised evidence is however absent and so they are not used routinely in this setting. 10 Prophylactic biological mesh implantation at time of stoma closure (to prevent incisional hernia) has not been tested in multicentre randomised studies. 10 The IDEAL framework describes a pathway for testing surgical devices and innovation.…”

“…10 Prophylactic biological mesh implantation at time of stoma closure (to prevent incisional hernia) has not been tested in multicentre randomised studies. 10 The IDEAL framework describes a pathway for testing surgical devices and innovation. 11 We described proof of concept in a single case (stage 1), 12 development in a short case series (stage 2A), exploration within a feasibility randomised trial (stage 2B), 13 and here describe assessment within a phase 3 randomised controlled trial (stage 3).…”

Invasive Candida albicans fungal infection requiring explantation of a noncrosslinked porcine derived biologic mesh: a rare but catastrophic complication in abdominal wall reconstruction

“…The direct advantages of biological mesh hence remain unproven despite their widespread usage. 11 Low-level evidence and opinion has inferred that biologic meshes are superior to synthetic prosthetic meshes in repairing complex and contaminated abdominal wall defects, including work published by our own group, 3,4,8,9,12,13 but long-term data on the safety and durability of biologic mesh in infected fields remains limited. A retrospective study by Rosen and colleagues reported an overall wound complication rate of 48% when biologic mesh was used in contaminated or complex abdominal fields using a single-staged approach.…”

Biocellulose for Incisional Hernia Repair—An Experimental Pilot Study

“…The main disadvantage is the high costs which go along with these biological meshes. Therefore, the meshes are mostly applied in the infectious situs after the explantation of an infected conventional mesh [ 11 ].…”