An interventional study of Standard (non-antiseptic coated) suture will be used. and Triclosan/antiseptic -coated suture in Pancreatoduodenectomy and Whipple Procedure, sponsored by The Cleveland Clinic. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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.
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.
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Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
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Exclusion Criteria:
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.
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
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
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.
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-operative
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-operative
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 operative
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-operative
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-operative
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 operative
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 operative
Surgical Site Infection
An infection that occurs in the part of the body where the surgery took place and includes superficial, deep, and organ space infections
Time frame: up to 90-day post operative
Surgical site occurrence
Non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous or purulent drainage, stitch abscess, seroma, hematoma, wound dehiscence, and enterocutaneous fistula
Time frame: Up to 90 days post-operative
Surgical Site Occurrence requiring Procedural Intervention
Interventions to address wound healing issues or complications including wound opening or debridement, suture excision, percutaneous drainage. This includes to address superficial, deep, and organ space healing concerns
Time frame: up to 90 days post-operative
Post operative pancreatic fistula interventions
Postoperative interventions related to clinically relevant postoperative pancreatic leak (defined by 2016 International Study Group of Pancreatic Fistula) including percutaneous, endoscopic and surgical interventions.
Time frame: Up to 90 days post-operative
Plan to share: No
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