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Recruiting

NCT Number: NCT06063577

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.

Recruiting

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Key information

Conditions

C.Surgical Procedure; Disruption of Wound, Suture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is a male or female 18 years of age or older.
  • Participant is a current patient at West Michigan Cancer Center.
  • Participant is undergoing liver, pancreas or biliary or gastrointestinal surgery of a combination of the above, or other major oncological surgery.
  • Participant is willing and able to provide written informed consent before surgery.

Exclusion criteria

  • Participant has hemodynamic instability at the conclusion of the surgery. (These subjects will be deemed disqualified).
  • Participant has history of previous VIH.
  • Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.

Treatment and study plan

Stratafix suture

Device

Stratafix symmetric suture

Standard of care suture

Device

Standard of care suture

Primary outcomes

  1. Number of participants who develop ventral incisional hernia

    Time frame: From enrollment to end of study participation at 12 months

    Infection, seroma, surgical site infection, evisceration, mesh rejection, systemic complications

Secondary outcomes

  1. Safety of stratafix sutures compared to standard of care wound closure

    Time frame: From enrollment to end of study participation at 12 months

    Assessing adverse events related to the suture

  2. Change in quality of life

    Time frame: "Month 1," "Month 3," "Month 6," "Month 12"

    Carolinas Comfort Scale (CCS) questionnaire (a validated, disease-specific, quality of life (QOL) questionnaire developed for patients undergoing hernia repair)

  3. Change in quality of life

    Time frame: "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.)

  4. Post operative pain

    Time frame: From enrollment to end of study participation at 12 months

    Visual analog score

Study contacts

Contact information is provided by the study sponsor or research team.

Wendi Mitchell

CONTACT

[email protected]

269-373-7443

Sponsors and collaborators

Lead sponsor

West Michigan Cancer Center

Other

Collaborators

  • Ethicon, Inc.

Registry information

Official study title

A Randomized Controlled Trial Evaluating the Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery

Acronym: STRATA-G

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2023
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.