Print

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

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

ArmDescriptionAssigned 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.
  • Device: Standard (non-antiseptic coated) suture will be used.
    This is an operation to treat tumors and other conditions in the pancreas, small intestine, and bile ducts. It involves removing the head of the pancreas, the first part of the small intestine, the gallbladder, and the bile duct. Part of the procedure involves sutures. A suture(s) is a stitch or row of stitches holding together the edges of a wound or surgical incision
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.
  • Device: Triclosan/antiseptic -coated suture
    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

Cleveland Clinic Akron
Akron 5145476, Ohio 5165418 44307
Contact:
Tom Callihan
330 344-6993
CALLIHT3@ccf.org

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Contact:
Divya Deverakonda, MD
216 379-3486
deverad3@ccf.org

Cleveland Clinic Fairview Hospital
Fairview 5153639, Ohio 5165418 44111
Contact:
Erica Linna, RN BSN
216 633-5073
LINNAE@ccf.org

More Details

Status
Recruiting
Sponsor
The Cleveland Clinic

Study Contact

Christine Moegling, BS
216 399-4706
Drabekc@ccf.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.