Antiseptic-coated sutures to reduce pancreatic fistula risk after Whipple
Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial
This trial tests whether using antiseptic-coated sutures during a Whipple procedure reduces the chance of developing a pancreatic fistula within 90 days after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 436 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 3 sites (Akron, Ohio and 2 other locations) |
| Trial ID | NCT07318493 on ClinicalTrials.gov |
What this trial studies
This randomized controlled superiority trial will assign adult patients undergoing a scheduled pancreatoduodenectomy (Whipple) to receive either antiseptic (triclosan)-coated sutures or standard non-coated sutures. The primary outcome is the rate of clinically significant postoperative pancreatic fistula within 90 days after surgery. Randomization occurs at Cleveland Clinic sites in Ohio and both suture types are already used at these centers. The goal is to see if the antiseptic coating lowers clinically important fistula rates compared with standard sutures.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for elective pancreatoduodenectomy who can provide informed consent and have not had prior pancreatic surgery are ideal candidates.
Not a fit: Patients undergoing emergency operations, those with prior pancreatic surgery, pregnant patients, minors, or people unable to consent are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, antiseptic-coated sutures could lower rates of postoperative pancreatic fistula and reduce related infections, reinterventions, and hospital stay.
How similar studies have performed: Triclosan-coated sutures have reduced surgical-site infections in some abdominal and general surgery studies, but evidence specifically showing reduced pancreatic fistula after Whipple procedures is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be undergoing a scheduled pancreatoduodenectomy. * Age ≥18 years. * Subjects must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients \< 18 years old * Patients who are pregnant * Patients with history of previous pancreatic surgery * Patients who are unable to provide informed consent
Where this trial is running
Akron, Ohio and 2 other locations
- Cleveland Clinic Akron — Akron, Ohio, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Cleveland Clinic Fairview Hospital — Fairview, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Toms Augustin, MD — The Cleveland Clinic
- Study coordinator: Christine Moegling, BS
- Email: Drabekc@ccf.org
- Phone: 216 399-4706
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.