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

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Whipple Procedure; Pancreatoduodenectomy

Treatments: Device: Triclosan/antiseptic -coated suture; Device: Standard (non-antiseptic coated) suture will be used.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07318493

24-575

Details and patient eligibility

About

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.

Full 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.

Enrollment: 436 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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436 participants in 2 patient groups

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

Other group

Description:

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

Treatment:

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

Triclosan/antiseptic -coated suture

Other group

Description:

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.

Treatment:

Device: Triclosan/antiseptic -coated suture