Randomized Trial Comparing Antiseptic-Coated Sutures to Standard Sutures to Prevent Pancreatic Fistulas After Pancreatoduodenectomy Surgery

What this Trial Is About

Researchers are evaluating whether antiseptic-coated sutures reduce the risk of postoperative pancreatic fistulas compared to standard sutures in patients undergoing pancreatoduodenectomy, a surgery involving removal of parts of the pancreas and nearby organs. This randomized controlled trial aims to see if using antiseptic-coated sutures can lower the rate of clinically significant fistulas within 90 days after surgery. Participants will be randomly assigned to receive either standard non-antiseptic sutures or triclosanantiseptic-coated sutures during their pancreatoduodenectomy. The antiseptic-coated sutures, specifically Ethicon PDS Plus Antibacterial Sutures, will be used at the pancreatojejunostomy layer throughout the surgery. Both sutures are commonly used at the study center. Participants will be followed for up to 90 days after surgery to monitor for postoperative pancreatic fistulas and surgical site infections. Researchers will assess outcomes such as fistula rates, infection rates, hospital and ICU length of stay, and any interventions needed for fistulas. The total participation period involves surgery and a 90-day postoperative observation to evaluate safety and effectiveness measures.

Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy