Safety and efficacy of prophylactic resorbable biosynthetic mesh following midline laparotomy in clean/contemned field: preliminary results of a randomized double blind prospectic trial.

The present randomized, double-blind study examines feasibility, safety and incisional hernia rate after prophylactic use of a Bio-A biosynthetic stripe (Gore) positioned sub-lay after median laparotomy in patients undergoing field operations clean-contaminated and contaminated. One hundred patients who underwent a median laparotomy of at least 10 cm in a clean-contaminated and contaminated field. The patients were divided into two groups [Group A closed in a double layer with PDS 0 with WL / SL of 1: 4; Group B closure in double layer with PDS 0 and positioning sub-lay strip of BIO A (Gore) of 3 cm wide extended for the entire length of the incision]. The primary objective of the study was to identify the incidence of IH in the two groups at a 1 and 2-year follow-up. Secondary objective was to identify any differences in the two groups in terms of post-operative pain, morbidity and mortality.The aim of the present study is to evaluate the effectiveness of IH prevention in patients undergoing laparotomy for clean-contaminated and contaminated surgery. The classification of wound contamination was assigned according to the likelihood and degree of wound contamination at the time of the operation, as stated in the Centre for Disease Control and Prevention (CDC) wound classification states(Grade II-III)(19) A double- blind, randomized, controlled trial will compare the running suture alone to versus the running suture, reinforced with biosynthetic mesh (BIO-A) in a sub lay fashion. The primary outcome will be IH rate at 6, 12 and 24 months postoperatively. Secondary outcomes measures will cover relevant postoperative complications (Clavien-Dindo) at 30- days and post-operative pain at 1 and 12 months with VAS score.(20)本项随机双盲临床试验，旨在评估接受清洁-污染及污染手术野手术的患者行正中剖腹术后，于筋膜下层植入Bio-A生物合成条带（戈尔（Gore）公司生产）进行预防性应用的可行性、安全性与切口疝（incisional hernia, IH）发生率。本研究共纳入100例于清洁-污染或污染手术野接受长度≥10cm正中剖腹术的患者，将其随机分为两组：A组采用0号PDS缝线行双层缝合，边距与缝距之比为1:4；B组同样采用0号PDS缝线行双层缝合，同时于切口全长植入宽3cm的Bio-A（戈尔公司）生物合成条带并置于筋膜下层。本研究的主要终点为随访1年及2年时两组的切口疝发生率，次要终点为比较两组患者术后疼痛、并发症发生率及死亡率的差异。本研究旨在评估针对接受清洁-污染及污染手术的患者行剖腹术后，切口疝预防措施的有效性。伤口污染分级参照美国疾病控制与预防中心（Centers for Disease Control and Prevention, CDC）的伤口分类标准（Ⅱ~Ⅲ级）(19)，依据手术当时伤口污染的可能性及程度进行划分。本项双盲随机对照试验将比较单纯连续缝合与连续缝合联合筋膜下层植入Bio-A生物合成网片（BIO-A）加固的手术效果。研究的主要结局指标为术后6、12及24个月的切口疝发生率，次要结局指标包括术后30天的相关并发症（克拉维埃-丁多（Clavien-Dindo）并发症分级系统评估）以及术后1、12个月的视觉模拟评分法（Visual Analogue Scale, VAS）疼痛评分(20)。