Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
STRATA-G
A Randomized Controlled Trial Evaluating the Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
1 other identifier
interventional
100
1 country
1
Brief Summary
Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
September 2, 2023
CompletedFirst Posted
Study publicly available on registry
October 2, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 2, 2024
January 1, 2024
3 years
September 2, 2023
January 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 (4)
Safety of stratafix sutures compared to standard of care wound closure
From enrollment to end of study participation at 12 months
Change in quality of life
"Month 1," "Month 3," "Month 6," "Month 12"
Change in quality of life
"Day 1," "Month 1," "Month 3," "Month 6," "Month 12"
Post operative pain
From enrollment to end of study participation at 12 months
Study Arms (2)
Stratafix Group
ACTIVE COMPARATORStratafix
Control Group
PLACEBO COMPARATORStandard of care
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- West Michigan Cancer Centerlead
- Ethicon, Inc.collaborator
Study Sites (1)
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Gitonga Munene
West Michigan Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Patients will be blinded after the assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 2, 2023
First Posted
October 2, 2023
Study Start
December 1, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 2, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share