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NCT07318493NARecruiting

Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

The Cleveland Clinic

Start Date

1/13/2026

Completion Date

2/1/2031

Summary

The purpose of this study is to determine if the use of antiseptic-coated sutures is better than the use of the standard sutures in preventing postoperative fistulas within 90 days after pancreatoduodenectomy.

Detailed Description

This study is a randomized-controlled trial comparing the rate of post-operative pancreatic fistula (POPF) in patients undergoing pancreatoduodenectomy. This is a superiority study designed to determine whether the use of antiseptic-coated sutures (intervention arm) is superior to standard sutures (control arm) in regard to clinically significant POPF within 90 days following pancreatoduodenectomy. Patients will be randomized to receive either a pancreatoduodenectomy surgery utilizing antiseptic coated sutures or with non-coated standard sutures. The study hypothesize that the use of antiseptic-coated sutures will be associated with a reduction in the rate of POPF. Both sutures are currently available at our center and utilized in the procedure of interest.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Standard (non-antiseptic coated) suture will be used.

DEVICE

Triclosan/antiseptic -coated suture

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Conditions

PancreatoduodenectomyWhipple Procedure

Locations

Cleveland Clinic Akron

Akron, Ohio 44307

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Cleveland Clinic Fairview Hospital

Fairview, Ohio 44111

United States