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