Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

This study is investigating whether using sutures coated with an antiseptic called triclosan (Ethicon PDSTM Plus Antibacterial Suture) can better prevent a complication called a postoperative pancreatic fistula (a leak from the pancreas after surgery) compared to standard, non-antiseptic coated sutures. This research focuses on patients undergoing a pancreatoduodenectomy (Whipple procedure), a surgery for conditions affecting the pancreas, small intestine, and bile ducts. The study aims to see if the antiseptic sutures reduce the rate of these fistulas within 90 days after surgery. You may be able to join if you are 18 or older, are scheduled for a pancreatoduodenectomy, and can provide informed consent. The current status of this study is unclear.

Study design
This is a randomized-controlled study comparing two types of sutures in patients undergoing pancreatoduodenectomy, with a planned enrollment of 436 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 90 days after surgery to check for postoperative pancreatic fistula.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07318493

Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

Recruiting
NAAges 18+InterventionalTreatment
The Cleveland Clinic
~436 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:Standard (non-antiseptic coated) suture will be used.Triclosan/antiseptic -coated suture

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of the rate of postoperative pancreatic fistula
Measured over up to 90 days post-operative
+2 more outcomes measured
Pancreatoduodenectomy
Whipple Procedure
3 sites across 1 states
Ohio3
  • Toms Augustin, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Patients \< 18 years old
Patients who are pregnant
Patients with history of previous pancreatic surgery
Patients who are unable to provide informed consent
  • Comparison of the rate of postoperative pancreatic fistulaup to 90 days post-operative

    comparison of the rate of postoperative pancreatic fistula- Biochemical leak

  • Comparison of the rate of postoperative pancreatic fistulaup to 90 days post-operative

    Comparison of the rate of postoperative pancreatic fistula-Grade B

  • Comparison of the rate of postoperative pancreatic fistulaup to 90-day post operative

    Comparison of the rate of postoperative pancreatic fistula-Grade C