Antiseptic-Coated Sutures for Whipple Procedure
(Triclosan Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether antiseptic-coated sutures, which have a germ-killing coating, can better prevent complications after a pancreatoduodenectomy (also known as the Whipple procedure). Researchers aim to determine if these sutures are more effective at preventing postoperative fistulas, which are unwanted openings that can form after surgery. The trial compares two groups: one using antiseptic-coated sutures and the other using standard sutures. It seeks participants who are scheduled for this surgery and can sign a consent form themselves. As an unphased trial, this study offers participants the chance to contribute to important research that could improve surgical outcomes for future patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that antiseptic-coated sutures are safe for use in surgery?
Research has shown that triclosan-coated stitches are generally safe for surgeries. One study found that these stitches reduced the risk of infections at the surgery site by 28%, indicating they are usually well-accepted by patients. Another study found that using these stitches in some surgeries led to fewer infections and complications like fistulas, which are unusual connections between organs. This suggests their safety and effectiveness. Reports also noted no deep infections and fewer harmful bacteria with these stitches. Overall, the evidence supports that triclosan-coated stitches are safe and can help reduce post-surgery complications.12345
Why are researchers excited about this trial?
Researchers are excited about antiseptic-coated sutures for the Whipple procedure because they use triclosan, an antibacterial agent, to reduce the risk of infection during and after surgery. Unlike standard sutures, which do not have antimicrobial properties, these sutures aim to prevent bacterial colonization at the surgical site. By potentially lowering infection rates, this approach could lead to fewer complications, faster recovery times, and improved outcomes for patients undergoing this complex surgery.
What evidence suggests that antiseptic-coated sutures are effective in preventing postoperative fistulas?
Research has shown that triclosan-coated stitches can greatly reduce the risk of infections at surgical sites. For example, studies have found that these stitches lower the chance of infections by 28% compared to regular stitches. In this trial, one group will receive triclosan/antiseptic-coated sutures during their Whipple procedure, potentially reducing the risk of developing pancreatic fistulas, a common issue in pancreatic surgeries. Another group will receive standard (non-antiseptic coated) sutures. This makes triclosan-coated stitches a promising choice for better surgical outcomes.12356
Who Is on the Research Team?
Toms Augustin, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who are scheduled to undergo a pancreatoduodenectomy (Whipple Procedure) and can understand and sign an informed consent. It's not specified who cannot join, but typically those with conditions affecting the surgery's safety would be excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo pancreatoduodenectomy surgery using either antiseptic-coated or standard sutures
Post-operative Monitoring
Participants are monitored for postoperative pancreatic fistula and other complications
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Triclosan/antiseptic-coated suture
Trial Overview
The study is testing if antiseptic-coated sutures reduce the risk of postoperative fistulas compared to standard sutures in patients after pancreatoduodenectomy. The effectiveness will be observed within 90 days following the procedure.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
You will undergo your primary surgery per standard practice at the discretion of your surgeon. Standard Sutures will be used during your operation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
Ethicon, Inc.
Industry Sponsor
Tim Schmid
Ethicon, Inc.
Chief Executive Officer since 2023
Undergraduate degree from the University of Western Ontario, MBA from Richmond University in the United Kingdom
Nancy Sabin
Ethicon, Inc.
Chief Medical Officer
MBA from the University of Pennsylvania’s Wharton School of Business, B.S. in Engineering from Duke University
Citations
Safety and Effectiveness of Triclosan-Coated ...
The use of PDS Plus in hypospadias surgery significantly reduces the incidence of SSI, postoperative fistulas, and reoperation rates compared to PDS II.
Ethicon Plus Antibacterial Sutures - J&J MedTech
Extensive clinical data shows a 28% reduction in SSI risk through the use of triclosan-coated sutures.JK3. Triclosan has in vitro activity that inhibits ...
3.
ctv.veeva.com
ctv.veeva.com/study/antiseptic-coated-sutures-and-pancreatic-fistula-risk-after-pancreatoduodenectomyAntiseptic-Coated Sutures and Pancreatic Fistula Risk After ...
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 ...
4.
accessdata.fda.gov
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=22457921&pc=NEWMAUDE Adverse Event Report: ETHICON INC. PDS LL PLUS ...
This prospective comparative study aims to compare the efficacy of triclosan-coated polydioxanone sutures ... triclosan-coated suture group ...
Triclosan-coated abdominal closure sutures reduce the ...
Conclusions: The use of triclosan-coated sutures may help reduce the incidence of SSI after PD compared with conventional non-antibiotic sutures. Publication ...
Triclosan coated sutures: an overview of safety and efficacy ...
Triclosan-impregnated sutures to decrease surgical site infections: systematic review and meta-analysis of randomized trials.
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