NCT07218679Active, not recruitingNot Applicable
Clinical Trial on the Use of Stratafix Symmetric vs. Resorbable Monofilament for Closure of Large Median Laparotomy in Oncological Patients
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 site in 1 country140 target enrollmentStarted: May 21, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Incisional hernia
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Stratafix
Experimental
Midline laparotomy closure with Stratafix suture.
Intervention: Stratafix Suture (Device)
PDS plus
Active Comparator
Midline laparotomy closure with PDS plus suture
Intervention: PDS plus suture (Device)
Outcomes
Primary Outcomes
Incisional hernia
Time Frame: 12 months
Incisional hernia rate after midline laparotomy closure.
Secondary Outcomes
- Wound infection(12 months.)
- Wound seroma(12 months)
- Hematoma(12 months)
- Evisceration(1 month)
Investigators
Study Sites (1)
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