Williams Christina P, Rosen Michael J, Jin Judy, McGee Michael F, Schomisch Steve J, Ponsky Jeffery
University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA.
Surg Innov. 2008 Dec;15(4):307-11. doi: 10.1177/1553350608327168.
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.
中线剖腹手术后的腹部筋膜缝合可能耗时且不准确，并且是针刺伤的常见发生时段。SuturTek 360度筋膜闭合装置（FCD）旨在实现安全的筋膜闭合，同时降低针刺伤风险。迄今为止，该装置所实现的筋膜闭合的准确性和有效性从未得到客观确定。对10头平均体重18千克的猪实施安乐死并进行中线剖腹手术。通过筋膜预先标记出理想的缝合位置。然后将这些动物随机分配接受传统缝合闭合或FCD筋膜闭合。指导外科医生通过理想标记处放置缝线。随后根据筋膜闭合时间和与标记的距离对外科医生进行评估。使用测压气球获取腹部破裂压力。还在体外模型上测试了准确性，再次要求参与者尽可能靠近理想标记处放置缝线，并计算与理想位置的绝对距离。与传统闭合相比，FCD导致闭合时间更快（5.9±0.6分钟对7.7±1.0分钟，P = 0.012），与理想标记的放置准确性相似（1.5±1.4毫米对0.8±1.1毫米）。两组之间的破裂压力相似：FCD组为470±71毫米汞柱，传统闭合组为453±94毫米汞柱（P = 0.76）。与传统开放技术相比，FCD能实现更快的筋膜闭合，且准确性和强度相似。严重针刺伤潜在的减少值得进行前瞻性试验。
