Blair A Wormer1, Ciara R Huntington1, Samuel W Ross1, Paul D Colavita1, Amy E Lincourt1, Tanushree Prasad1, Ronald F Sing1, Stanley B Getz2, Igor Belyansky3, B Todd Heniford1, Vedra A Augenstein4. 1. Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina. 2. Division of Plastic Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina. 3. Department of Surgery, Anne Arundel Medical Center, Annapolis, Maryland. 4. Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina. Electronic address: vedra.augenstein@carolinashealthcare.org.
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/m(2); 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 < 0.0001). There was no difference between groups in rates of skin necrosis (6.1% versus 2.2%; P = 0.3), fat necrosis (10.2% versus 13.0%, P = 0.7), reoperation (14.3% versus 26.1%, P = 0.7), wound infection (10.2% versus 21.7%; P = 0.12), or overall wound-related complications (32.7% versus 37.0%, P = 0.7). Skin/subcutaneous hypoperfusion on ICG-FA was associated with higher rates of wound infection (28% versus 9.4%, P < 0.02), but flap modification after viewing images did not prevent wound-related complications (15.6% versus 12.5%, P = 0.99). CONCLUSIONS: This is the first randomized, double-blinded, controlled trial to evaluate ICG-FA in abdominal wall reconstruction. Although ICG-FA guidance and intraoperative modification of flaps did not prevent wound-related complications or reoperation, it did identify at risk patients.
RCT Entities:
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/m(2); 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 < 0.0001). There was no difference between groups in rates of skin necrosis (6.1% versus 2.2%; P = 0.3), fat necrosis (10.2% versus 13.0%, P = 0.7), reoperation (14.3% versus 26.1%, P = 0.7), wound infection (10.2% versus 21.7%; P = 0.12), or overall wound-related complications (32.7% versus 37.0%, P = 0.7). Skin/subcutaneous hypoperfusion on ICG-FA was associated with higher rates of wound infection (28% versus 9.4%, P < 0.02), but flap modification after viewing images did not prevent wound-related complications (15.6% versus 12.5%, P = 0.99). CONCLUSIONS: This is the first randomized, double-blinded, controlled trial to evaluate ICG-FA in abdominal wall reconstruction. Although ICG-FA guidance and intraoperative modification of flaps did not prevent wound-related complications or reoperation, it did identify at risk patients.
Authors: Anouk J M Cornelissen; Tom J M van Mulken; Caitlin Graupner; Shan S Qiu; Xavier H A Keuter; René R W J van der Hulst; Rutger M Schols Journal: Eur J Plast Surg Date: 2018-02-27
Authors: Takeaki Ishizawa; Peter McCulloch; Derek Muehrcke; Thomas Carus; Ory Wiesel; Giovanni Dapri; Sylke Schneider-Koriath; Steven D Wexner; Mahmoud Abu-Gazala; Luigi Boni; Elisa Cassinotti; Charles Sabbagh; Ronan Cahill; Frederic Ris; Michele Carvello; Antonino Spinelli; Eric Vibert; Muga Terasawa; Mikiya Takao; Kiyoshi Hasegawa; Rutger M Schols; Tim Pruimboom; Yasuo Murai; Fumihiro Matano; Michael Bouvet; Michele Diana; Norihiro Kokudo; Fernando Dip; Kevin White; Raul J Rosenthal Journal: BMJ Surg Interv Health Technol Date: 2021-10-19