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Recruiting NCT06063577

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

No phase Interventional C.Surgical Procedure; Disruption of Wound, Suture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stratafix suture, Standard of care suture.
Who it may be relevant to
Registry conditions: C.Surgical Procedure; Disruption of Wound, Suture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Stratafix suture
    Stratafix symmetric suture
  • Device Standard of care suture
    Standard of care suture

Primary outcome measures

  • Number of participants who develop ventral incisional hernia [Time frame: From enrollment to end of study participation at 12 months]
Secondary outcome measures (4)
  • Safety of stratafix sutures compared to standard of care wound closure [Time frame: From enrollment to end of study participation at 12 months]
  • Change in quality of life [Time frame: "Month 1," "Month 3," "Month 6," "Month 12"]
  • Change in quality of life [Time frame: "Day 1," "Month 1," "Month 3," "Month 6," "Month 12"]
  • Post operative pain [Time frame: From enrollment to end of study participation at 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • West Michigan Cancer Center — Kalamazoo

Identifiers

NCT: NCT06063577 · 001-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗