Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

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.

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.

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