Overview
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.
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.
Eligibility
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