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Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

NCT07318493 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Pancreatoduodenectomy
  • Whipple Procedure

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.

Sponsors & Collaborators

  • Ethicon, Inc.

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Toms Augustin, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2030-12-31
Completion
2031-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07318493 on ClinicalTrials.gov