Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Ohio
Cleveland Clinic Akron
RECRUITING
Akron
Cleveland Clinic
RECRUITING
Cleveland
Cleveland Clinic Fairview Hospital
RECRUITING
Fairview
Contact Information
Primary
Christine Moegling, BS
Drabekc@ccf.org
216 399-4706
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2031-02
Participants
Target number of participants: 436
Treatments
Other: Standard (non-antiseptic coated) suture will be used.
You will undergo your primary surgery per standard practice at the discretion of your surgeon. Standard Sutures will be used during your operation.
Other: Triclosan/antiseptic -coated suture
You will undergo your primary surgery per standard practice at the discretion of your surgeon. 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.
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic
Collaborators: Ethicon, Inc.