Evaluating the need for antibiotics after salivary duct stent placement
Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement
PHASE4 · Our Lady of the Lake Hospital · NCT03333408
This study is testing if patients who have a salivary duct stent placed really need antibiotics after surgery to prevent infections.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Our Lady of the Lake Hospital (other) |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT03333408 on ClinicalTrials.gov |
What this trial studies
This study investigates whether postoperative antibiotics are necessary for patients who have undergone salivary duct stent placement. It involves adult patients who will be randomly assigned to receive either postoperative antibiotics or no antibiotics following their surgery. The aim is to assess the potential risks associated with antibiotic use, such as gastrointestinal disturbances and antibiotic resistance, against the benefits of preventing infections. The study is conducted at Our Lady of the Lake Regional Medical Center in Baton Rouge, Louisiana.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing salivary duct surgery and stent placement.
Not a fit: Patients with acute infections, immunocompromised conditions, or those unwilling to participate in the randomized assignment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce unnecessary antibiotic use and its associated side effects in patients undergoing salivary duct procedures.
How similar studies have performed: Other studies have shown mixed results regarding the necessity of postoperative antibiotics in surgical scenarios, indicating that this investigation is relevant and timely.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patients with acute infections at the time of surgery * Patients who are immunocompromised * Patients who are recruited but then have early dislodgement of the stent * 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. * Patients who are in the non-post operative antibiotic arm but choose to put themselves on antibiotics without consultation from the physician
Where this trial is running
Baton Rouge, Louisiana
- Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States (RECRUITING)
Study contacts
- Principal investigator: Rohan Walvekar, M.D. — Our Lady of the Lake Hospital
- Study coordinator: Rohan Walvekar, M.D.
- Email: rwalve@lsuhsc.edu
- Phone: 225-765-1765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Salivary Duct