Use of Stratafix Symmetric™ to Prevent Incisional Hernia... | NCT06063577

Studies
Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery

NCT06063577

Sponsor

West Michigan Cancer Center

Status

Recruiting

Last Update Posted

Feb 2, 2024Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

C.Surgical Procedure; Disruption of Wound, Suture

Interventions

Stratafix suture
Standard of care suture

Countries

United States

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 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Sep 2, 2023

First Submission Date that Met QC Criteria

Sep 28, 2023

First Posted Date

Oct 2, 2023Actual

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 31, 2024

Last Update Posted Date

Feb 2, 2024Actual

Name	Class
Ethicon, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.

Detailed Description

Determine whether the use of Stratafix Symmetric™ sutures reduces the development of Ventral Incisional Hernia (VIH) in patients undergoing complex GI surgery compared to standard laparotomy closure. Determine the safety of Stratafix Symmetric™ sutures compared to standard laparotomy closure sutures and the impact on quality of life and level of pain.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stratafix Group	Active Comparator	Stratafix	Device: Stratafix suture
Control Group	Placebo Comparator	Standard of care	Device: Standard of care suture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stratafix suture	Device	Stratafix symmetric suture	Stratafix Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants who develop ventral incisional hernia	Infection, seroma, surgical site infection, evisceration, mesh rejection, systemic complications	From enrollment to end of study participation at 12 months

Secondary Outcomes

Measure	Description	Time Frame
Safety of stratafix sutures compared to standard of care wound closure	Assessing adverse events related to the suture	From enrollment to end of study participation at 12 months
Change in quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant is a male or female 18 years of age or older.
Participant is a current patient at West Michigan Cancer Center.
Participant is undergoing liver, pancreas or biliary or gastrointestinal surgery of a combination of the above, or other major oncological surgery.
Participant is willing and able to provide written informed consent before surgery.

Exclusion Criteria:

Participant has hemodynamic instability at the conclusion of the surgery. (These subjects will be deemed disqualified).
Participant has history of previous VIH.
Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wendi Mitchell	Contact	269-373-7443		research@wmcc.org

Overall Officials

Name	Affiliation	Role
Gitonga Munene	West Michigan Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West Michigan Cancer Center	Recruiting	Kalamazoo	Michigan	49007	United States

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