Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy
This study is investigating whether using sutures coated with an antiseptic called triclosan (Ethicon PDSTM Plus Antibacterial Suture) can better prevent a complication called a postoperative pancreatic fistula (a leak from the pancreas after surgery) compared to standard, non-antiseptic coated sutures. This research focuses on patients undergoing a pancreatoduodenectomy (Whipple procedure), a surgery for conditions affecting the pancreas, small intestine, and bile ducts. The study aims to see if the antiseptic sutures reduce the rate of these fistulas within 90 days after surgery. You may be able to join if you are 18 or older, are scheduled for a pancreatoduodenectomy, and can provide informed consent. The current status of this study is unclear.
- Study design
- This is a randomized-controlled study comparing two types of sutures in patients undergoing pancreatoduodenectomy, with a planned enrollment of 436 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 90 days after surgery to check for postoperative pancreatic fistula.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy
At a glance
Conditions
Where it's being run
3 sites across 1 statesStudy leadership
- Toms Augustin, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Comparison of the rate of postoperative pancreatic fistulaup to 90 days post-operative
comparison of the rate of postoperative pancreatic fistula- Biochemical leak
- Comparison of the rate of postoperative pancreatic fistulaup to 90 days post-operative
Comparison of the rate of postoperative pancreatic fistula-Grade B
- Comparison of the rate of postoperative pancreatic fistulaup to 90-day post operative
Comparison of the rate of postoperative pancreatic fistula-Grade C