Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

NCT07318493 | Recruiting DMC FDA Device

• 1 other identifier: 24-575
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 3

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.

Conditions

Pancreatoduodenectomy; Whipple Procedure

Keywords

pancreatoduodenectomy; whipple procedure; sutures

Outcome Measures

Primary Outcomes (3)

• Comparison of the rate of postoperative pancreatic fistula

  comparison of the rate of postoperative pancreatic fistula- Biochemical leak

  up to 90 days post-operative

• Comparison of the rate of postoperative pancreatic fistula

  Comparison of the rate of postoperative pancreatic fistula-Grade B

  up to 90 days post-operative

• Comparison of the rate of postoperative pancreatic fistula

  Comparison of the rate of postoperative pancreatic fistula-Grade C

  up to 90-day post operative

Secondary Outcomes (8)

• Improvement in Rate of clinically significant POPF

  up to 90-days post-operative

• Improvement in SSI rates between groups using CDC classification

  up to 90-days post-operative

• Hospital Length of Stay

  up to 90-day post operative

• Length of ICU stay

  up to 90-day post operative

• Surgical Site Infection

  up to 90-day post operative

Study Arms (2)

Standard (non-antiseptic coated) suture will be used.

OTHER

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.

Triclosan/antiseptic -coated suture

OTHER

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

Interventions

Standard (non-antiseptic coated) suture will be used. DEVICE

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

Standard (non-antiseptic coated) suture will be used.

Triclosan/antiseptic -coated suture DEVICE

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.

Triclosan/antiseptic -coated suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients \< 18 years old
• Patients who are pregnant
• Patients with history of previous pancreatic surgery
• Patients who are unable to provide informed consent

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Ethicon, Inc.: collaborator

Study Sites (3)

Cleveland Clinic Akron

Akron, Ohio, 44307, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Cleveland Clinic Fairview Hospital

Fairview, Ohio, 44111, United States

RECRUITING

Related Publications (8)

• Shubert CR, Wagie AE, Farnell MB, Nagorney DM, Que FG, Reid Lombardo KM, Truty MJ, Smoot RL, Kendrick ML. Clinical Risk Score to Predict Pancreatic Fistula after Pancreatoduodenectomy: Independent External Validation for Open and Laparoscopic Approaches. J Am Coll Surg. 2015 Sep;221(3):689-98. doi: 10.1016/j.jamcollsurg.2015.05.011. Epub 2015 May 21.

  PMID: 26296680 BACKGROUND

• Shubert CR, Kendrick ML, Habermann EB, Glasgow AE, Borah BJ, Moriarty JP, Cleary SP, Smoot RL, Farnell MB, Nagorney DM, Truty MJ, Que FG. Implementation of prospective, surgeon-driven, risk-based pathway for pancreatoduodenectomy results in improved clinical outcomes and first year cost savings of $1 million. Surgery. 2018 Mar;163(3):495-502. doi: 10.1016/j.surg.2017.10.022. Epub 2017 Dec 21.

  PMID: 29275974 BACKGROUND

• Ocuin LM, Loftus A, Elshami M, Hue JJ, Musonza T, Ammori JB, Winter JM, Hardacre JM. Extended antibiotic therapy is associated with a lower rate of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy in intermediate- and high-risk patients: A single-institution analysis. Surgery. 2024 Feb;175(2):477-483. doi: 10.1016/j.surg.2023.09.049. Epub 2023 Nov 7.

  PMID: 37940433 BACKGROUND

• Riall TS, Nealon WH, Goodwin JS, Townsend CM Jr, Freeman JL. Outcomes following pancreatic resection: variability among high-volume providers. Surgery. 2008 Aug;144(2):133-40. doi: 10.1016/j.surg.2008.03.041.

  PMID: 18656618 BACKGROUND

• Krautz C, Nimptsch U, Weber GF, Mansky T, Grutzmann R. Effect of Hospital Volume on In-hospital Morbidity and Mortality Following Pancreatic Surgery in Germany. Ann Surg. 2018 Mar;267(3):411-417. doi: 10.1097/SLA.0000000000002248.

  PMID: 28379871 BACKGROUND

• Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.

  PMID: 28040257 BACKGROUND

• Yang YM, Tian XD, Zhuang Y, Wang WM, Wan YL, Huang YT. Risk factors of pancreatic leakage after pancreaticoduodenectomy. World J Gastroenterol. 2005 Apr 28;11(16):2456-61. doi: 10.3748/wjg.v11.i16.2456.

  PMID: 15832417 BACKGROUND

• Sato N, Yamaguchi K, Chijiiwa K, Tanaka M. Risk analysis of pancreatic fistula after pancreatic head resection. Arch Surg. 1998 Oct;133(10):1094-8. doi: 10.1001/archsurg.133.10.1094.

  PMID: 9790207 BACKGROUND

Study Officials

• Toms Augustin, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Moegling, BS

CONTACT

216 399-4706; Drabekc@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director (Main Campus) - Safety, Quality and Patient Experience

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 6, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): February 1, 2031
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)