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
Qualifiers
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
Treatments tested in this trial
- Standard (non-antiseptic coated) suture will be used.
- Triclosan/antiseptic -coated suture
Treatment groups
436 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Cleveland Clinic
Lead sponsor
Ethicon, Inc.
Collaborator
Source ClinicalTrials.gov