title: A prospective randomized double-blinded controlled trial evaluating indocyanine green fluorescence angiography on reducing wound complications in complex abdominal wall reconstruction.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.affiliation: Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Blair A
authors.initials: BA
authors.lastname: Wormer
authors.affiliation: Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Ciara R
authors.initials: CR
authors.lastname: Huntington
authors.affiliation: Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Samuel W
authors.initials: SW
authors.lastname: Ross
authors.affiliation: Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Colavita
authors.affiliation: Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Amy E
authors.initials: AE
authors.lastname: Lincourt
authors.affiliation: Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Tanushree
authors.initials: T
authors.lastname: Prasad
authors.affiliation: Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Ronald F
authors.initials: RF
authors.lastname: Sing
authors.affiliation: Division of Plastic Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Stanley B
authors.initials: SB
authors.lastname: Getz
authors.affiliation: Department of Surgery, Anne Arundel Medical Center, Annapolis, Maryland.
authors.forename: Igor
authors.initials: I
authors.lastname: Belyansky
authors.affiliation: Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: B Todd
authors.initials: BT
authors.lastname: Heniford
authors.affiliation: Division of Gastrointestinal and Minimally Invasive Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina. Electronic address: vedra.augenstein@carolinashealthcare.org.
authors.forename: Vedra A
authors.initials: VA
authors.lastname: Augenstein
mesh_terms: D034861:Abdominal Wall / Q000098:blood supply / Q000601:surgery; D061645:Abdominoplasty; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography / Q000379:methods*; D005456:Fluorescent Dyes; D005500:Follow-Up Studies; D046449:Hernia, Abdominal / Q000601:surgery*; D059685:Herniorrhaphy / Q000379:methods*; D006801:Humans; D007208:Indocyanine Green; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D012086:Reoperation; D013524:Surgical Flaps / Q000098:blood supply*; D016896:Treatment Outcome; D014945:Wound Healing; D055815:Young Adult
chemical_list: D005456:Fluorescent Dyes; D007208:Indocyanine Green
keywords: Abdominal wall reconstruction; ICG; Indocyanine green angiography; Panniculectomy; Randomized trial; Wound complication