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

Not Applicable

Recruiting

• Conditions: C.Surgical Procedure; Disruption of Wound, Suture
• Interventions: Device: Standard of care suture; Device: Stratafix suture

• Registration Number: NCT06063577
• Lead Sponsor: West Michigan Cancer Center

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.

Study Timeline

• Study First Submitted: 2023-09-02
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-02
• Study Start: 2023-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard of care suture	Standard of care
Stratafix Group	Stratafix suture	Stratafix

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	"Day 1," "Month 1," "Month 3," "Month 6," "Month 12"	Functional Assessment of Cancer Therapy-G (FACT-G) questionnaire (a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being.)
Post operative pain	From enrollment to end of study participation at 12 months	Visual analog score
Safety of stratafix sutures compared to standard of care wound closure	From enrollment to end of study participation at 12 months	Assessing adverse events related to the suture

Trial Locations

Locations (1)

West Michigan Cancer Center; 🇺🇸 Kalamazoo, Michigan, United States