PancreatoduodenectomyTriclosanNCT07318493
Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy
A study testing Standard (non-antiseptic coated) suture will be used. and Triclosan/antiseptic -coated suture in people with Pancreatoduodenectomy and Whipple Procedure, run by The Cleveland Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatoduodenectomy, Whipple Procedure
- What is being tested?
- Standard (non-antiseptic coated) suture will be used. and Triclosan/antiseptic -coated suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jan 2026to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients < 18 years old
- Patients who are pregnant
- Patients with history of previous pancreatic surgery
- Patients who are unable to provide informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Cleveland Clinic Akron
Akron, Ohio, 44307
Tom Callihan, 330 344-6993, CALLIHT3@ccf.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Divya Deverakonda, MD, 216 379-3486, deverad3@ccf.org
Noah Tocci, MD, 216 346-1447, toccin@ccf.org
- Recruiting
Cleveland Clinic Fairview Hospital
Fairview, Ohio, 44111
Erica Linna, RN BSN, 216 633-5073, LINNAE@ccf.org
Shweta Josh, 216 312-6601, JOSHS@ccf.org
About this study
Official title: Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled 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.
Read the 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.
- Conditions
- Pancreatoduodenectomy, Whipple Procedure
- Being tested
- Standard (non-antiseptic coated) suture will be used., Triclosan/antiseptic -coated suture
- Keywords
- pancreatoduodenectomy, whipple procedure, sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Triclosan/antiseptic -coated sutureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Triclosan/antiseptic -coated suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the rate of postoperative pancreatic fistula
comparison of the rate of postoperative pancreatic fistula- Biochemical leak
Measured: up to 90 days post-operative
Comparison of the rate of postoperative pancreatic fistula
Comparison of the rate of postoperative pancreatic fistula-Grade B
Measured: up to 90 days post-operative
Comparison of the rate of postoperative pancreatic fistula
Comparison of the rate of postoperative pancreatic fistula-Grade C
Measured: up to 90-day post operative
Secondary outcomes (8)
Improvement in Rate of clinically significant POPF
Improvement in Rate of clinically significant POPF (Grade B and C defined by ISGLS definition)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 90 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start13 Jan 2026
- Primary completionDec 2030 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PancreatoduodenectomyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Principal investigator, Toms Augustin, The Cleveland Clinic
- Investigators
- Toms Augustin, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318493
- Sponsor's protocol ID
- 24-575
- Acronym
- Triclosan
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26296680Shubert 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.
PubMed 29275974Ocuin 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.
PubMed 37940433Riall 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.
PubMed 18656618Krautz 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.
PubMed 28379871Bassi 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.
PubMed 28040257Yang 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.
PubMed 15832417Sato 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.
PubMed 9790207
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07318493
- Acronym / sponsor ID
- Triclosan / 24-575
- Conditions
- Pancreatoduodenectomy, Whipple Procedure
- Keywords
- pancreatoduodenectomy, whipple procedure, sutures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 436 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard (non-antiseptic coated) suture will be used. | Other | Device: 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. |
| Triclosan/antiseptic -coated suture | Other | Device: Triclosan/antiseptic -coated sutureYou 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patients < 18 years old
- Patients who are pregnant
- Patients with history of previous pancreatic surgery
- Patients who are unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Standard (non-antiseptic coated) suture will be used. |
| Triclosan/antiseptic -coated sutureTriclosan/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 |
Primary outcome
Comparison of the rate of postoperative pancreatic fistula
Time frame: up to 90 days post-operative
comparison of the rate of postoperative pancreatic fistula- Biochemical leak
Comparison of the rate of postoperative pancreatic fistula
Time frame: up to 90 days post-operative
Comparison of the rate of postoperative pancreatic fistula-Grade B
Comparison of the rate of postoperative pancreatic fistula
Time frame: up to 90-day post operative
Comparison of the rate of postoperative pancreatic fistula-Grade C
8 secondary outcomes
Improvement in Rate of clinically significant POPF
Time frame: up to 90-days post-operative
Improvement in SSI rates between groups using CDC classification
Time frame: up to 90-days post-operative
Hospital Length of Stay
Time frame: up to 90-day post operative
Length of ICU stay
Time frame: up to 90-day post operative
Surgical Site Infection
Time frame: up to 90-day post operative
Surgical site occurrence
Time frame: Up to 90 days post-operative
Surgical Site Occurrence requiring Procedural Intervention
Time frame: up to 90 days post-operative
Post operative pancreatic fistula interventions
Time frame: Up to 90 days post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 26296680Shubert 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.
- Background: PubMed 29275974Shubert 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.
- Background: PubMed 37940433Ocuin 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.
- Background: PubMed 18656618Riall 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.
- Background: PubMed 28379871Krautz 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.
- Background: PubMed 28040257Bassi 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.
- Background: PubMed 15832417Yang 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.
- Background: PubMed 9790207Sato 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Toms Augustin, MD principal investigator
The Cleveland Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard (non-antiseptic coated) suture will be used. and Triclosan/antiseptic -coated suture in people with Pancreatoduodenectomy and Whipple Procedure, run by The Cleveland Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Moegling, BS (216 399-4706, Drabekc@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the rate of postoperative pancreatic fistula (time frame: up to 90 days post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07318493, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.