NCT04356976

Brief Summary

Randomised controlled trial comparing Ventralex Hernia Patch with Stratafix suture for repair of primary ventral hernias in the midline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

3.9 years

First QC Date

April 19, 2020

Last Update Submit

January 1, 2025

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

  • Hernia recurrence

    Recurrence diagnosed at clinical and/or radiologic examination

    One year

Secondary Outcomes (4)

  • Rate of intra-and postoperative complications

    30 days

  • Rate of seroma development

    one year

  • Persisting pain

    One year

  • Mean number of days postoperative sick leave

    30 days

Study Arms (2)

Ventralex

EXPERIMENTAL

Repair with Ventralex hernia patch in sublay position

Device: Ventralex

Stratafix

ACTIVE COMPARATOR

Repair with Stratafix suture

Other: Stratafix

Interventions

VentralexDEVICE

Repair of hernia using Ventralex patch in sublay position

Ventralex
StratafixOTHER

Repair of hernia without mesh. Defect closed with Stratafix suture.

Stratafix

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Defect 1-4 cm
  • Primary ventral hernia in the midline
  • BMI\<35

You may not qualify if:

  • Defect \>4cm
  • BMI\>35
  • Recurrent hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karlskoga Hospital

Karlskoga, Sweden

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Gabriel Sandblom, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient and the staff responsible for the postoperative care of the patient will be masked for the allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial comparing Ventralex hernia patch with Stratafix sutures for repair of primary ventral hernias
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2020

First Posted

April 22, 2020

Study Start

January 1, 2021

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

January 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)