Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy
Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial
The Cleveland Clinic
436 participants
Jan 13, 2026
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
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
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
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)
View Full Details on ClinicalTrials.gov
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NCT07318493