Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:20 AM
Study NCT ID:
NCT07318493
Status:
RECRUITING
Last Update Posted:
2026-01-21
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Triclosan
Brief 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.
Detailed 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 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: