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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07218679

Acronym

ONCOSTRAT

Enrollment

140

Registered

2025-10-20

Start date

2025-05-21

Completion date

2028-02-28

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia After Midline Laparotomy

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.

Interventions

DEVICEStratafix Suture

Midline laparotomy closure using Stratafix vs PDS plus.

DEVICEPDS plus suture

Midline laparotomy closure using PDS plus.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Incisional hernia	12 months	Incisional hernia rate after midline laparotomy closure.

Secondary

Measure	Time frame	Description
Wound infection	12 months.	Compare the wound infection rate after midline laparotomy closure with Stratafix vs PDS plus.
Wound seroma	12 months	Compare the wound seroma rate after midline laparotomy closure with Stratafix vs PDS plus.
Hematoma	12 months	Compare the hematoma rate after midline laparotomy closure with Stratafix vs PDS plus.
Evisceration	1 month	Compare the evisceration rate after midline laparotomy closure with Stratafix vs PDS plus.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026