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
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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ACTIVE_NOT_RECRUITING
NA
140 participants
INTERVENTIONAL
2025-05-21
2028-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Stratafix
Midline laparotomy closure with Stratafix suture.
Stratafix Suture
Midline laparotomy closure using Stratafix vs PDS plus.
PDS plus
Midline laparotomy closure with PDS plus suture
PDS plus suture
Midline laparotomy closure using PDS plus.
Interventions
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Stratafix Suture
Midline laparotomy closure using Stratafix vs PDS plus.
PDS plus suture
Midline laparotomy closure using PDS plus.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Locations
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Hospital Universitario Virgen del Rocio
Seville, , Spain
Countries
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Other Identifiers
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FIS-STRA-2024-01
Identifier Type: -
Identifier Source: org_study_id
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