Status:
RECRUITING
Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
Lead Sponsor:
West Michigan Cancer Center
Collaborating Sponsors:
Ethicon, Inc.
Conditions:
C.Surgical Procedure; Disruption of Wound, Suture
Eligibility:
All Genders
18+ years
Phase:
NA
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06063577
Start Date
December 1 2023
End Date
December 1 2026
Last Update
February 2 2024
Active Locations (1)
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1
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007