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Clinical Trials in Spain / NCT07218679
Active, not recruiting Not applicable

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

NCT07218679 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Phase
Not applicable
Started
2025-05-21
Last updated
2025-10-20

Condition(s) studied

Incisional Hernia After Midline Laparotomy

Investigational drug(s) / intervention(s)

Stratafix SuturePDS plus suture

Stratafix Suture: Midline laparotomy closure using Stratafix vs PDS plus.

PDS plus suture: Midline laparotomy closure using PDS plus.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Incisional hernia — 12 months
    Incisional hernia rate after midline laparotomy closure.

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario Virgen del Rocio Seville Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07218679 on ClinicalTrials.gov ↗ ← All trials in Spain