Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial
The Cleveland Clinic
Summary
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 antisepti…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceStandard (non-antiseptic coated) suture will be used.
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
- DeviceTriclosan/antiseptic -coated suture
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.
Locations (3)
- Cleveland Clinic AkronAkron, Ohio
- Cleveland ClinicCleveland, Ohio
- Cleveland Clinic Fairview HospitalFairview, Ohio