METHODS: This is a prospective multicentre observational cohort study. Preliminary results from the first 3 months are presented. We included general surgical patients who had at least two risk factors for developing an incisional hernia. Multivariate logistic regression was used. A polyvinylidene fluoride (PVDF) mesh loaded with iron particles was used in an onlay position. MRIs were performed 6 weeks after treatment.
RESULTS: Between July 2016 and June 2022, 185 patients were enrolled in the study. Surgery was emergent in 30.3% of cases, contaminated in 10.7% and dirty in 11.8%. A total of 5.6% of cases had postoperative wound infections, with the requirement of stoma being the only significant risk factor (OR = 7.59, p = 0.03). The formation of a seroma at 6 weeks detected by MRI, was associated with body mass index (OR = 1.13, p = 0.02).
CONCLUSIONS: The prophylactic use of onlay PVDF mesh in midline laparotomies in high-risk patients was safe and effective in the short term, regardless of the type of surgery or the level of contamination. MRI allowed us to detect asymptomatic seromas during the early process of integration.
BACKGROUND: This protocol was registered at ClinicalTrials.gov (NCT03105895).
方法:这是一项前瞻性多中心观察性队列研究。给出了前3个月的初步结果。我们纳入了至少有两个发生切口疝的危险因素的普外科患者。采用多因素logistic回归分析。负载有铁颗粒的聚偏二氟乙烯(PVDF)网被用于上置式位置。治疗后6周进行MRI检查。
结果:在2016年7月至2022年6月之间,185名患者被纳入研究。30.3%的病例出现紧急手术,污染占10.7%,污染占11.8%。共有5.6%的病例出现术后伤口感染,造口的需求是唯一重要的危险因素(OR=7.59,p=0.03)。通过MRI检测到6周血清肿的形成,与体重指数相关(OR=1.13,p=0.02)。
结论:在高风险患者的中线开腹手术中预防性使用onlayPVDF网片在短期内是安全有效的,无论手术类型或污染程度。MRI使我们能够在整合的早期过程中检测到无症状的血清瘤。
背景:该方案已在ClinicalTrials.gov(NCT03105895)注册。