跳至主要内容
临床试验/NCT05061264
NCT05061264已完成不适用

Complex Abdominal Wall Reconstruction With Polyvinylidene (PVDF) Mesh in the Setting of Active Infection: a Prospective Case-control Series.

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
2
主要终点
Surgical site infection

研究概览

简要总结

The use of synthetic mesh to repair infected defects of the abdominal wall remains controversial. This study aimed to evaluate the short-term outcomes of using PVDF mesh to treat infected abdominal wall defects in the elective setting.

详细描述

From May 2016 until February 2021, 38 patients presenting with chronic mesh infection and/or enteric fistulas were enrolled in this prospective study. The active infection group (AI) was compared to a cohort of 38 patients submitted to clean ventral hernia repairs (CC). The inclusion criteria in the AI group were the presence of active chronic mesh infection (non-healing sinus, exposed mesh, or mesh-related enteric fistulas) resulting from a previous repair, or the presence of an enteric/enteroatmospheric fistula, with or without an associated abdominal wall defect. The patients invited to participate as controls had a primary or recurrent ventral hernia without previous history of infection and were eligible for clean operations. The operations in the AI group were classified as Class IV (dirty-infected), according to the CDC Wound Classifications, as adopted by the European registry for abdominal wall hernias.

The exclusion criteria were giant ventral hernias, patients on immunosuppressive or corticosteroid therapy, patients with portal hypertension, Crohn's disease, acute postoperative mesh infection, chronic infections following inguinal hernia repair, and emergency operations.

Demographic data included age, gender, American Society of Anesthesiologists (ASA) score, body mass index (BMI), comorbidities, smoking status, cancer history, and the number of previous abdominal operations. Perioperative details included the list of associated procedures, the defect width, the extension of the pre-aponeurotic dissection, operative time, and anesthesia time. Further analysis in the AI group included the clinical presentation, the onset of symptoms, the type and position of the infected mesh, the possible causes for mesh infection, and the microbiology of mesh explants.

Patients were followed and operated at the Abdominal Wall and Hernia Repair Unit at the Hospital das Clínicas, University of São Paulo, Brazil. Six surgeons of the team conducted the operations in both groups. The local ethics committee approved the study. Informed consent was obtained from all individual participants. The study was registered at the national registry, Plataforma Brasil (https://plataformabrasil.saude.gov.br/login.jsf), CAAE 52383615.0.0000.0068, and Identifier 1.412.367.

All the mesh samples used were provided by the manufacturer (FEG Textiltechnik, Aachen, Germany) through their local dealer (BMR Medical, www.bmrmedical.com.br), at no cost. None of the authors or our institution received any financial support to undertake the study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 86 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Study group: patients with the presence of an active chronic mesh infection (non-healing sinus, exposed mesh, or mesh-related enteric fistulas) resulting from a previous repair, or the presence of an enteric/enteroatmospheric fistula, with or without an associated abdominal wall defect
  • Control group: patients with a primary or recurrent ventral hernia without previous history of infection and eligible for clean operations

排除标准

  • giant ventral hernias with a volume ratio higher than 25% and loss of domicile
  • patients on immunosuppressive therapy or using corticosteroids
  • patients with portal hypertension
  • patients with Chron´s disease
  • acute postoperative mesh infection
  • chronic mesh infections following inguinal hernia repair
  • emergency operations.

结局指标

主要结局

Surgical site infection

时间窗: 30 days

as an infection occurring where the surgery took place and was further defined as superficial, deep, and organ space

Surgical site occurence

时间窗: 30 days

any surgical infection, wound breakdown, soft tissue ischemia, seroma, and hematoma formation

次要结局

  • Hernia recurrence(6 and 36 months)
  • Infection recurrence(6 and 36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudio Birolini

MD, phD. Director of General Surgery of the Third Division of Clinical Surgery of the Department of Surgery, Head of the Hernias and Abdominal Wall Group

University of Sao Paulo General Hospital

研究点 (2)

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