NCT06063577NARecruiting
Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
West Michigan Cancer Center
Start Date
12/1/2023
Completion Date
12/1/2026
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
1. Participant is a male or female 18 years of age or older.
2. Participant is a current patient at West Michigan Cancer Center.
3. Participant is undergoing liver, pancreas or biliary or gastrointestinal surgery of a combination of the above, or other major oncological surgery.
4. Participant is willing and able to provide written informed consent before surgery.
Exclusion Criteria:
1. Participant has hemodynamic instability at the conclusion of the surgery. (These subjects will be deemed disqualified).
2. Participant has history of previous VIH.
3. Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.
Interventions
DEVICE
Stratafix suture
DEVICE
Standard of care suture
Conditions
C.Surgical Procedure; Disruption of Wound, Suture
Locations
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United States