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

NCT ID: NCT07218679

Last Updated: 2025-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-21

Study Completion Date

2028-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Incisional Hernia After Midline Laparotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Stratafix

Midline laparotomy closure with Stratafix suture.

Group Type EXPERIMENTAL

Stratafix Suture

Intervention Type DEVICE

Midline laparotomy closure using Stratafix vs PDS plus.

PDS plus

Midline laparotomy closure with PDS plus suture

Group Type ACTIVE_COMPARATOR

PDS plus suture

Intervention Type DEVICE

Midline laparotomy closure using PDS plus.

Interventions

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Stratafix Suture

Midline laparotomy closure using Stratafix vs PDS plus.

Intervention Type DEVICE

PDS plus suture

Midline laparotomy closure using PDS plus.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FIS-STRA-2024-01

Identifier Type: -

Identifier Source: org_study_id

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