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NCT Number: NCT07218679

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Incisional Hernia After Midline Laparotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stratafix suture

Device

Midline laparotomy closure using Stratafix vs PDS plus.

PDS plus suture

Device

Midline laparotomy closure using PDS plus.

Primary outcomes

  1. Incisional hernia

    Time frame: 12 months

    Incisional hernia rate after midline laparotomy closure.

Secondary outcomes

  1. Wound infection

    Time frame: 12 months.

    Compare the wound infection rate after midline laparotomy closure with Stratafix vs PDS plus.

  2. Wound seroma

    Time frame: 12 months

    Compare the wound seroma rate after midline laparotomy closure with Stratafix vs PDS plus.

  3. Hematoma

    Time frame: 12 months

    Compare the hematoma rate after midline laparotomy closure with Stratafix vs PDS plus.

  4. Evisceration

    Time frame: 1 month

    Compare the evisceration rate after midline laparotomy closure with Stratafix vs PDS plus.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Acronym: ONCOSTRAT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 20, 2025
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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