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

Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.

Study Overview

• Status: Recruiting
• Conditions: C.Surgical Procedure; Disruption of Wound, Suture
• Intervention / Treatment: Device: Stratafix suture; Device: Standard of care suture

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendi Mitchell; Phone Number: 269-373-7443; Email: research@wmcc.org

Study Locations

• United States
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Recruiting
      • West Michigan Cancer Center
      • Contact: Kathleen Allen; Phone Number: 269-373-7452; Email: kallen@wmcc.org
      • Contact: Wendi Mitchell; Phone Number: 269-373-7443; Email: wmitchell@wmcc.org
      • Principal Investigator: Gitonga Munene, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stratafix Group; Stratafix	Device: Stratafix suture; Stratafix symmetric suture
Placebo Comparator: Control Group; Standard of care	Device: Standard of care suture; Standard of care suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of stratafix sutures compared to standard of care wound closure	Assessing adverse events related to the suture	From enrollment to end of study participation at 12 months
Change in quality of life	Carolinas Comfort Scale (CCS) questionnaire (a validated, disease-specific, quality of life (QOL) questionnaire developed for patients undergoing hernia repair)	"Month 1," "Month 3," "Month 6," "Month 12"
Post operative pain	Visual analog score	From enrollment to end of study participation at 12 months
Change in quality of life	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.)	"Day 1," "Month 1," "Month 3," "Month 6," "Month 12"

Collaborators and Investigators

• Sponsor: West Michigan Cancer Center
• Collaborators: Ethicon, Inc.
• Investigators: Principal Investigator: Gitonga Munene, West Michigan Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 2, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 001-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes