A prospective randomized double-blinded controlled trial evaluating indocyanine green fluorescence angiography on reducing wound complications in complex abdominal wall reconstruction

Abstract Background The purpose of this prospective, randomized, double-blinded controlled trial was to investigate the utility of indocyanine green fluorescence angiography (ICG-FA) in reducing wound complications in complex abdominal wall reconstruction. Materials and methods All consented patients underwent ICG-FA with SPY Elite after hernia repair and before flap closure. They were randomized into the control group, in which the surgical team was blinded to ICG-FA images and performed surgery as they normally would, or the experimental group, in which the surgery team viewed the images and could modify tissue flaps according to their findings. Patient variables and wound complications were compared with standard statistical methods. Results Among 95 patients, n = 49 control versus n = 46 experimental, preoperative characteristics were similar including age (58.3 versus 56.7 y; P = 0.4), body mass index (34.9 versus 33.6 kg/m2 ; P = 0.8), tobacco use (8.2% versus 8.7%; P = 0.9), diabetes (30.6% versus 37.0%; P = 0.5), and previous hernia repair (71.4% versus 60.9%; P = 0.3). Operative characteristics were also similar, including rate of panniculectomy (69.4% versus 58.7%; P = 0.3) and component separation (73.5% versus 69.6%; P = 0.6). The experimental group more often had advancement flaps modified (37% versus 4.1%, P