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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

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Conditions

C.Surgical Procedure; Disruption of Wound, Suture

Locations

West Michigan Cancer Center

Kalamazoo, Michigan 49007

United States