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RECRUITING
NCT07318493
NA

Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

436

Start Date

2026-01-13

Completion Date

2031-02

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

DEVICE

Standard (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

DEVICE

Triclosan/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