Objective Analysis of the Accuracy and Efficacy of a Novel Fascial Closure Device

Abstract

Abdominal fascial closure after midline laparotomy can be time-consuming and inaccurate and is a common time for needle-stick injuries. The SuturTek 360 degrees Fascial Closure Device (FCD) is designed to provide a secure fascial closure while reducing the risk of needle-stick injury. To date, the accuracy and efficacy of the fascial closure obtained with this device have never been objectively determined. Ten pigs averaging 18 kg were killed and underwent a midline laparotomy. Idealized suture locations were premarked through the fascia. The animals were then randomly assigned to either a traditional suture closure or the FCD for fascial closure. Surgeons were instructed to place sutures through the idealized markers. Surgeons were then evaluated based on the time to close fascia and distance from the markers. Abdominal bursting pressures were obtained using a manometric balloon. Accuracy was also tested on an ex vivo model on which the participants were again asked to place stitches as close as possible to idealized marks, and absolute distance from the idealized location was calculated. The FCD resulted in a faster closure time when compared with traditional closure (5.9 +/- 0.6 vs 7.7 +/- 1.0 minute, P = .012), with a similar accuracy of placement from the idealized markers (1.5 +/- 1.4 mm vs 0.8 +/- 1.1 mm). Bursting pressures were similar between the 2 groups: 470 +/- 71 mm Hg for FCD versus 453 +/- 94 mm Hg for traditional closure ( P = .76). The FCD resulted in a faster fascial closure with similar accuracy and strength when compared with traditional open techniques. The potential reduction in serious needle-stick injuries warrants prospective trials.