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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Patients \< 18 years old
Patients who are pregnant
Patients with history of previous pancreatic surgery
Patients who are unable to provide informed consent
Clareo Health | Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy
