Comparative Study Between the Use of Tubular Drains in Closed Suction System and the Use of Progressive Tension Sutures in Prevention of Infection and Seromas After Surgical Repair of Large Incisional Hernias

The present randomised clinical trial was approved by the research ethics committees of the São Paulo School of Medicine - Federal University of São Paulo (Universidade Federal de São Paulo - UNIFESP), the State University of Western Paraná (Universidade Estadual do Oeste do Paraná - UNIOESTE) and the University Hospital of Western Paraná (Hospital Universitário do Oeste do Paraná - HUOP) in compliance with the 1964 Declaration of Helsinki and later updates.

The study design and randomisation followed the Consolidated Standards of Reporting Trials (CONSORT) version 2010 15.

All the participants read and signed an informed consent form at the preoperative assessment visit.

Inclusion and exclusion criteria Individuals with primary or recurrent incisional hernia were assessed at HUOP, and those with longitudinal or transverse ventral hernia secondary to a previous surgical incision, measuring 5 to 15 cm after dissection of the hernial sac and classified as large or very large according to Chevrel's classification, were considered to be eligible16. In individuals with multiple defects, the length between the cranial margin of the most cranial defect and the caudal margin of the most caudal defect was considered17. Individuals subjected to emergency surgery, with infection, immunosuppressed, younger than 18 or older than 80 years old, ASA III or IV, with a serum albumin concentration lower than 3.0 g/dl or who refused participation were excluded from the study.

Surgical technique The participants were admitted to the hospital the night before surgery to perform or update the assessment of their surgical risk according to the American Society of Anesthesiologists (ASA) criteria, as well as for measurement of the serum albumin concentration.