Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy
Purpose
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.
Conditions
- Pancreatoduodenectomy
- Whipple Procedure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Akron 5145476, Ohio 5165418 44307
Cleveland 5150529, Ohio 5165418 44195
Fairview 5153639, Ohio 5165418 44111
More Details
- NCT ID
- NCT07318493
- Status
- Recruiting
- Sponsor
- The Cleveland Clinic
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.