Recruiting

Antiseptic-Coated Sutures

Sponsor:

The Cleveland Clinic

Code:

NCT07318493

Conditions

Pancreatoduodenectomy

Whipple Procedure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard (non-antiseptic coated) suture will be used.

Triclosan/antiseptic -coated suture

Study Details

Brief 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

Study ID

NCT07318493

Start date

Jan 13, 2026

Status verified date

Jan, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

436 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

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.

Primary outcome measure

  • Comparison of the rate of postoperative pancreatic fistula [ Time Frame: 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 [ Time Frame: up to 90-day post operative ]

Central Contacts and Locations

Central contacts

Christine Moegling, BS

216 399-4706Drabekc@ccf.org

Locations

Cleveland Clinic Akron

Recruiting

Akron, Ohio, United States, 44307

Contacts

Tom Callihan

330 344-6993CALLIHT3@ccf.org

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Divya Deverakonda, MD

216 379-3486deverad3@ccf.org

Noah Tocci, MD

216 346-1447toccin@ccf.org

Cleveland Clinic Fairview Hospital

Recruiting

Fairview, Ohio, United States, 44111

Contacts

Erica Linna, RN BSN

216 633-5073LINNAE@ccf.org

Shweta Josh

216 312-6601JOSHS@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • pancreatoduodenectomy
  • whipple procedure
  • sutures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-01-21.