Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy (Triclosan)

January 19, 2026 updated by: Toms Augustin, The Cleveland Clinic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized-controlled trial comparing the rate of post-operative pancreatic fistula (POPF) in patients undergoing pancreatoduodenectomy. This is a superiority study designed to determine whether the use of antiseptic-coated sutures (intervention arm) is superior to standard sutures (control arm) in regard to clinically significant POPF within 90 days following pancreatoduodenectomy. Patients will be randomized to receive either a pancreatoduodenectomy surgery utilizing antiseptic coated sutures or with non-coated standard sutures. The study hypothesize that the use of antiseptic-coated sutures will be associated with a reduction in the rate of POPF. Both sutures are currently available at our center and utilized in the procedure of interest.

Study Type

Interventional

Enrollment (Estimated)

436

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christine Moegling, BS
  • Phone Number: 216 399-4706
  • Email: Drabekc@ccf.org

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44307
        • Recruiting
        • Cleveland Clinic Akron
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Contact:
      • Fairview, Ohio, United States, 44111
        • Recruiting
        • Cleveland Clinic Fairview Hospital
        • Contact:
          • Erica Linna, RN BSN
          • Phone Number: 216 633-5073
          • Email: LINNAE@ccf.org
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard (non-antiseptic coated) suture will be used.
You will undergo your primary surgery per standard practice at the discretion of your surgeon. Standard Sutures will be used during your operation.
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
Other: Triclosan/antiseptic -coated suture
You will undergo your primary surgery per standard practice at the discretion of your surgeon. 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the rate of postoperative pancreatic fistula
Time Frame: up to 90 days post-operative
comparison of the rate of postoperative pancreatic fistula- Biochemical leak
up to 90 days post-operative
Comparison of the rate of postoperative pancreatic fistula
Time Frame: up to 90 days post-operative
Comparison of the rate of postoperative pancreatic fistula-Grade B
up to 90 days post-operative
Comparison of the rate of postoperative pancreatic fistula
Time Frame: up to 90-day post operative
Comparison of the rate of postoperative pancreatic fistula-Grade C
up to 90-day post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Rate of clinically significant POPF
Time Frame: up to 90-days post-operative
Improvement in Rate of clinically significant POPF (Grade B and C defined by ISGLS definition)
up to 90-days post-operative
Improvement in SSI rates between groups using CDC classification
Time Frame: up to 90-days post-operative
Improvement in SSI rates between groups using CDC classification (superficial, deep, organ space)
up to 90-days post-operative
Hospital Length of Stay
Time Frame: up to 90-day post operative
Duration of hospital admission, measured in days, during index presentation for pancreatoduodenectomy. This will subsequently be compared among our two cohorts (standard suture vs antiseptic suture)
up to 90-day post operative
Length of ICU stay
Time Frame: up to 90-day post operative
Duration of Intensive care unit admission, measured in days, during index presentation for pancreatoduodenectomy, or during convalescence from surgery. This will subsequently be compared among our two cohorts (standard suture vs antiseptic suture)
up to 90-day post operative
Surgical Site Infection
Time Frame: up to 90-day post operative
An infection that occurs in the part of the body where the surgery took place and includes superficial, deep, and organ space infections
up to 90-day post operative
Surgical site occurrence
Time Frame: Up to 90 days post-operative
Non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous or purulent drainage, stitch abscess, seroma, hematoma, wound dehiscence, and enterocutaneous fistula
Up to 90 days post-operative
Surgical Site Occurrence requiring Procedural Intervention
Time Frame: up to 90 days post-operative
Interventions to address wound healing issues or complications including wound opening or debridement, suture excision, percutaneous drainage. This includes to address superficial, deep, and organ space healing concerns
up to 90 days post-operative
Post operative pancreatic fistula interventions
Time Frame: Up to 90 days post-operative
Postoperative interventions related to clinically relevant postoperative pancreatic leak (defined by 2016 International Study Group of Pancreatic Fistula) including percutaneous, endoscopic and surgical interventions.
Up to 90 days post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Ethicon, Inc.

Investigators

  • Principal Investigator: Toms Augustin, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24-575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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