RecruitingNot ApplicableNCT07318493

Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial


Sponsor

The Cleveland Clinic

Enrollment

436 participants

Start Date

Jan 13, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • Patients < 18 years old
  • Patients who are pregnant
  • Patients with history of previous pancreatic surgery
  • Patients who are unable to provide informed consent

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Interventions

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

This is an operation to treat tumors and other conditions in the pancreas, small intestine, and bile ducts. It involves removing the head of the pancreas, the first part of the small intestine, the gallbladder, and the bile duct. Part of the procedure involves sutures. A suture(s) is a stitch or row of stitches holding together the edges of a wound or surgical incision

DEVICETriclosan/antiseptic -coated suture

Triclosan/antiseptic -coated suture will be used. Ethicon PDSTM Plus Antibacterial Suture will be used at the layer of the pancreatojejunostomy and for the duration of the case.


Locations(3)

Cleveland Clinic Akron

Akron, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Cleveland Clinic Fairview Hospital

Fairview, Ohio, United States

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NCT07318493


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