RECRUITING

Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Salivary duct stent placement is a common practice to maintain duct patency after salivary duct repair or interventional sialoendoscopy; procedures performed to manage salivary duct pathology such as stenosis, traumatic injury or most commonly salivary duct stones. It is common practice for patients to receive perioperative antibiotics while undergoing interventional sialoendoscopy and postoperative oral antibiotic therapy with Clindamycin or Augmentin for 10-14 days, if a short term (2 week) salivary duct stenting was considered necessary due to the nature of the intervention. However, In reviewing the literature, there are controversial trials that indicate post-operative antibiotics may not be best practice in all surgical scenarios, as the adverse events ie. gastrointestinal disturbances, nausea, Clostridium difficile (C.diff) infection and antibiotic resistance over time surrounding overuse of antibiotics may outweigh the clinical need for the antibiotic regiment and the chances of post-operative infection.

Official Title

Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement

Quick Facts

Study Start:2018-06-15
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03333408

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All adult patients (18 years of age or older) who are undergoing salivary duct surgery and stent placement at Our Lady of the Lake Regional Medical Center
  1. * Patients who are unwilling to consent to the study and/or to being placed in a randomized arm of either receiving post-operative antibiotics or not receiving post-operative antibiotics
  2. * Patients with acute infections at the time of surgery
  3. * Patients who are immunocompromised
  4. * Patients who are recruited but then have early dislodgement of the stent
  5. * Patients who do not complete their postoperative antibiotic therapy due to intolerance or antibiotic side effects. However, data on these patients will be recorded to provide an observational results that will support the need for this investigation on antibiotic use.
  6. * Patients who are in the non-post operative antibiotic arm but choose to put themselves on antibiotics without consultation from the physician

Contacts and Locations

Study Contact

Rohan Walvekar, M.D.
CONTACT
225-765-1765
rwalve@lsuhsc.edu
Leslie Son, Ph.D.
CONTACT
225-757-4165
lson@lsuhsc.edu

Principal Investigator

Rohan Walvekar, M.D.
PRINCIPAL_INVESTIGATOR
Our Lady of the Lake Hospital

Study Locations (Sites)

Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
United States

Collaborators and Investigators

Sponsor: Our Lady of the Lake Hospital

  • Rohan Walvekar, M.D., PRINCIPAL_INVESTIGATOR, Our Lady of the Lake Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-15
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2018-06-15
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Salivary Duct