Antiseptic-Coated Sutures for Whipple Procedure

(Triclosan Trial)

Overseen By Christine Moegling, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Pregnancy, Previous pancreatic surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this 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.

Who Is on the Research Team?

Toms Augustin, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are scheduled to undergo a pancreatoduodenectomy (Whipple Procedure) and can understand and sign an informed consent. It's not specified who cannot join, but typically those with conditions affecting the surgery's safety would be excluded.

Inclusion Criteria

I can understand and am willing to sign the consent form.

I am 18 years old or older.

I am scheduled for a pancreatoduodenectomy surgery.

Exclusion Criteria

Patients who are pregnant

I am under 18 years old.

I have had surgery on my pancreas before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo pancreatoduodenectomy surgery using either antiseptic-coated or standard sutures

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for postoperative pancreatic fistula and other complications

90 days

Regular follow-up visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Triclosan/antiseptic-coated suture

Trial Overview

The study is testing if antiseptic-coated sutures reduce the risk of postoperative fistulas compared to standard sutures in patients after pancreatoduodenectomy. The effectiveness will be observed within 90 days following the procedure.

How Is the Trial Designed?

Group I: Triclosan/antiseptic -coated suture Experimental Treatment 1 Intervention

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.

Group II: Standard (non-antiseptic coated) suture will be used. Experimental Treatment 1 Intervention

You will undergo your primary surgery per standard practice at the discretion of your surgeon. Standard Sutures will be used during your operation.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Ethicon, Inc.

Industry Sponsor

Trials

95

Recruited

62,300+

Tim Schmid

Ethicon, Inc.

Chief Executive Officer since 2023

Undergraduate degree from the University of Western Ontario, MBA from Richmond University in the United Kingdom

Nancy Sabin

Ethicon, Inc.

Chief Medical Officer

MBA from the University of Pennsylvania’s Wharton School of Business, B.S. in Engineering from Duke University