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

Last updated: January 31, 2024
Sponsor: West Michigan Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

Stratafix suture

Standard of care suture

Clinical Study ID

NCT06063577
001-2023
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 acombination of the above, or other major oncological surgery.
  4. Participant is willing and able to provide written informed consent before surgery.

Exclusion

Exclusion Criteria:

  1. Participant has hemodynamic instability at the conclusion of the surgery. (Thesesubjects will be deemed disqualified).
  2. Participant has history of previous VIH.
  3. Participant has a mental condition rendering the subject incapable of understandingthe nature, scope and consequences of the study.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Stratafix suture
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • West Michigan Cancer Center

    Kalamazoo, Michigan 49007
    United States

    Active - Recruiting

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