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

NCT07218679 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-10-20

No results posted yet for this 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.

Conditions

  • Incisional Hernia After Midline Laparotomy

Interventions

DEVICE

Stratafix Suture

Midline laparotomy closure using Stratafix vs PDS plus.

DEVICE

PDS plus suture

Midline laparotomy closure using PDS plus.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-21
Primary Completion
2028-02-28
Completion
2028-02-28
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07218679 on ClinicalTrials.gov