Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients < 18 years old
Patients who are pregnant
Patients with history of previous pancreatic surgery
Patients who are unable to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Standard (non-antiseptic coated) suture will be used.
DeviceThis 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
Triclosan/antiseptic -coated suture
DeviceTriclosan/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.
Treatment groups
436 Participants
are divided into 2 treatment groupsGroup A: Standard (non-antiseptic coated) suture will be used.Other 1 intervention
Group B: Triclosan/antiseptic -coated sutureOther 1 intervention
Trial outcomes
Primary outcomes
1
Comparison of the rate of postoperative pancreatic fistula
comparison of the rate of postoperative pancreatic fistula- Biochemical leak
Time frame
up to 90 days post-operative2
Comparison of the rate of postoperative pancreatic fistula
Comparison of the rate of postoperative pancreatic fistula-Grade B
Time frame
up to 90 days post-operative3
Comparison of the rate of postoperative pancreatic fistula
Comparison of the rate of postoperative pancreatic fistula-Grade C
Time frame
up to 90-day post operativeSecondary outcomes
1
Improvement in Rate of clinically significant POPF
Improvement in Rate of clinically significant POPF (Grade B and C defined by ISGLS definition)
Time frame
up to 90-days post-operative2
Improvement in SSI rates between groups using CDC classification
Improvement in SSI rates between groups using CDC classification (superficial, deep, organ space)
Time frame
up to 90-days post-operative3
Hospital Length of Stay
Duration of hospital admission, measured in days, during index presentation for pancreatoduodenectomy. This will subsequently be compared among our two cohorts (standard suture vs antiseptic suture)
Time frame
up to 90-day post operative4
Length of ICU stay
Duration of Intensive care unit admission, measured in days, during index presentation for pancreatoduodenectomy, or during convalescence from surgery. This will subsequently be compared among our two cohorts (standard suture vs antiseptic suture)
Time frame
up to 90-day post operativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Cleveland Clinic
Lead sponsor
Ethicon, Inc.
Collaborator
Source ClinicalTrials.gov