NCT07218679

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
May 2025Feb 2028

Study Start

First participant enrolled

May 21, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

October 20, 2025

Status Verified

July 1, 2025

Enrollment Period

2.8 years

First QC Date

October 16, 2025

Last Update Submit

October 16, 2025

Conditions

Incisional Hernia After Midline Laparotomy

Outcome Measures

Primary Outcomes (1)

  • Incisional hernia

    Incisional hernia rate after midline laparotomy closure.

    12 months

Secondary Outcomes (4)

  • Wound infection

    12 months.

  • Wound seroma

    12 months

  • Hematoma

    12 months

  • Evisceration

    1 month

Study Arms (2)

Stratafix

EXPERIMENTAL

Midline laparotomy closure with Stratafix suture.

Device: Stratafix Suture

PDS plus

ACTIVE COMPARATOR

Midline laparotomy closure with PDS plus suture

Device: PDS plus suture

Interventions

Stratafix SutureDEVICE

Midline laparotomy closure using Stratafix vs PDS plus.

Stratafix
PDS plus sutureDEVICE

Midline laparotomy closure using PDS plus.

PDS plus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2025

First Posted

October 20, 2025

Study Start

May 21, 2025

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2028

Last Updated

October 20, 2025

Record last verified: 2025-07

Locations

ES(1)