Using Stratafix sutures to prevent hernias after abdominal surgery
A Randomized Controlled Trial Evaluating the Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
This study is testing whether using Stratafix sutures instead of regular sutures can help prevent hernias and improve recovery for patients having complex abdominal surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | West Michigan Cancer Center Academic / other |
| Locations | 1 site (Kalamazoo, Michigan) |
| Trial ID | NCT06063577 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of Stratafix Symmetric™ sutures against standard sutures in preventing Ventral Incisional Hernia (VIH) in patients undergoing complex gastrointestinal surgeries. It aims to assess not only the reduction in hernia development but also the safety of Stratafix sutures and their impact on patients' quality of life and pain levels. Participants will be monitored for outcomes related to their surgical recovery and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing major gastrointestinal or oncological surgeries at the West Michigan Cancer Center.
Not a fit: Patients with a history of previous Ventral Incisional Hernia or those with hemodynamic instability at the conclusion of surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of hernias following major abdominal surgeries, improving recovery and quality of life for patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using advanced suturing techniques to reduce hernia rates, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kalamazoo, Michigan
- West Michigan Cancer Center — Kalamazoo, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Gitonga Munene — West Michigan Cancer Center
- Study coordinator: Wendi Mitchell
- Email: research@wmcc.org
- Phone: 269-373-7443
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.