Clinical Trial on the Use of Stratafix Symmetric vs. Resorbable Monofilament for Closure of Large Median Laparotomy in Oncological Patients (ONCOSTRAT)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Active, not recruiting

Conditions

Incisional Hernia After Midline Laparotomy

Treatments

Device: PDS plus suture

Device: Stratafix Suture

Study type

Interventional

Funder types

Other

Identifiers

NCT07218679

FIS-STRA-2024-01

Details and patient eligibility

About

The aim of this study is to evaluate the safety and efficacy of using Stratafix (a type of symmetric, barbed, and coated suture) for abdominal wall closure in oncologic patients undergoing elective midline laparotomy, compared to the use of a monofilament suture following the Small Stitch technique.

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients over 18 years of age who will undergo midline laparotomy for oncologic resection of a retroperitoneal tumor or cytoreductive surgery for carcinomatosis of any origin.

Exclusion criteria

Diagnosed incisional hernia.
When the planned midline laparotomy is expected to be less than 20 cm.
Patients with a BMI > 45 kg/m².
Patients with abdominal aortic aneurysm.
Patients with coagulopathy: previously diagnosed with von Willebrand disease, hemophilia, or idiopathic thrombocytopenic purpura.
Patients with collagen disorders: previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria, or scleroderma.