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Postoperative Antibiotics for Salivary Duct Procedures

Phase 4
Recruiting
Led By Rohan Walvekar, M.D.
Research Sponsored by Our Lady of the Lake Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
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 who are in the non-post operative antibiotic arm but choose to put themselves on antibiotics without consultation from the physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial examines the efficacy of postoperative antibiotics following salivary duct stent placement.

Who is the study for?
Adults over 18 needing salivary duct surgery and stent placement at Our Lady of the Lake Regional Medical Center can join. Excluded are those unwilling to be randomized, with acute infections, immunocompromised, early stent dislodgement, or who don't finish their antibiotics unless due to side effects.
What is being tested?
The trial is testing if taking oral antibiotics (Clindamycin or Augmentin) after salivary duct stent placement is necessary. Patients will either receive postoperative antibiotics for 10-14 days or none, to see if avoiding them reduces complications like gastrointestinal issues and antibiotic resistance.
What are the potential side effects?
Potential side effects from Clindamycin or Augmentin include stomach upset, nausea, diarrhea potentially leading to C.diff infection (a serious gut infection), and contributing to antibiotic resistance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an adult scheduled for salivary duct surgery with stent placement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am willing to participate in a study and accept random assignment regarding post-operative antibiotics.
Select...
I started taking antibiotics on my own without my doctor's advice.
Select...
I have a weakened immune system.
Select...
I have an active infection at the time of my surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Communicable Diseases

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Group B (no Antibiotic)Active Control1 Intervention
Group B will not be given postoperative oral antibiotics upon discharge.
Group II: Group A (Antibiotic)Active Control1 Intervention
Group A will receive postoperative oral antibiotics for 10 - 14 days (Clindamycin or Augmentin) upon discharge.

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansOTHER
120 Previous Clinical Trials
42,827 Total Patients Enrolled
Our Lady of the Lake HospitalLead Sponsor
13 Previous Clinical Trials
819 Total Patients Enrolled
Rohan Walvekar, M.D.Principal InvestigatorOur Lady of the Lake Hospital
~1 spots leftby Dec 2024
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