Ventralex Vs Stratafix for Primary Ventral Hernias | NCT04356976

Studies
Ventralex Vs Stratafix for Primary Ventral Hernias

NCT04356976

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Jan 3, 2025Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Ventral Hernia

Interventions

Ventralex
Stratafix

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Nov 30, 2024Actual

Completion Date

Nov 30, 2024Actual

First Submitted Date

Apr 19, 2020

First Submission Date that Met QC Criteria

Apr 21, 2020

First Posted Date

Apr 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 1, 2025

Last Update Posted Date

Jan 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Primary hernias in the midline, including umbilical hernias and epigastric hernias, are among the most common conditions requiring surgery.

Mesh-reinforced as well as suture repair are used for the treatment of primary hernias, but for smaller umbilical hernias (diameter 1-3cm), there is little evidence for the superiority of mesh repair. Despite the widely use of composite ventral patch, there are few studies showing the advantage and disadvantage of ventral patch. In recent years, the barbed suture has been widely used in umbilical and incisional hernias, in laparoscopic as well as in open surgery. However, there are no studies comparing ventral patch with slowly absorbable barbed suture in open surgery.

The investigators intend to compare the use of sublay composite mesh (ventral-patch) with non-resorbable barbed prolene suture repair only and investigate recurrence rate and other short and long-term postoperative complications in these two methods.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ventralex	Experimental	Repair with Ventralex hernia patch in sublay position	Device: Ventralex
Stratafix	Active Comparator	Repair with Stratafix suture	Other: Stratafix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ventralex	Device	Repair of hernia using Ventralex patch in sublay position	Ventralex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hernia recurrence	Recurrence diagnosed at clinical and/or radiologic examination	One year

Secondary Outcomes

Measure	Description	Time Frame
Rate of intra-and postoperative complications	Complications occurring intraoperatively or in the postoperative period	30 days
Rate of seroma development	Seroma confirmed at follow-up examination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Defect >4cm
BMI>35
Recurrent hernia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriel Sandblom, MD, PhD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karlskoga Hospital		Karlskoga			Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006555	Hernia, Ventral

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided