Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

Conditions

• Pancreatoduodenectomy
• Whipple Procedure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jan 13, 2026

Status verified

Jan 2026

Primary completion

Dec 31, 2030

Completion

Feb 28, 2031

Study Design

Enrollment

436 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Christine Moegling, BS
  216 399-4706
  [email protected]

Locations (3)

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