NCT06063577 · West Michigan Cancer Center
Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
(STRATA-G)
What this study is about
Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.
View original scientific description
Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.
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
Infection, seroma, surgical site infection, evisceration, mesh rejection, systemic complications
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Kalamazoo, Michigan
Collaborators
Ethicon, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 2, 2024 · Source of record for eligibility and locations