Antiseptic-coated sutures to reduce pancreatic fistula risk after Whipple

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using indocyanine green to check blood flow in the pancreatic remnant during pancreaticoduodenectomy

  This trial will try using indocyanine green during pancreaticoduodenectomy to visualize blood flow and see if that lowers postoperative pancreatic fistula in adults having the operation.

  Recruiting Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Girona, Girona · NCT07502053

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.