Postoperative Antibiotics for Salivary Duct Procedures

Overseen By Rohan Walvekar, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Our Lady of the Lake Hospital

Disqualifiers: Acute infections, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Rohan Walvekar, M.D.

Principal Investigator

Our Lady of the Lake Hospital

Eligibility Criteria

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.

Inclusion Criteria

I am an adult scheduled for salivary duct surgery with stent placement.

Exclusion Criteria

I have an active infection at the time of my surgery.

Patients who are recruited but then have early dislodgement of the stent

I started taking antibiotics on my own without my doctor's advice.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo salivary duct stent placement and receive perioperative antibiotics. Group A receives postoperative oral antibiotics for 10-14 days, while Group B does not receive postoperative antibiotics.

2 weeks

Follow-up

Participants are monitored for post-operative infection and other adverse events. The primary endpoint is assessed at the 2-week follow-up visit when the stent is removed.

2 weeks

Treatment Details

Interventions

• Augmentin
• Clindamycin

Trial Overview 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.

Participant Groups

Group I: Group B (no Antibiotic) Active Control 1 Intervention

Group B will not be given postoperative oral antibiotics upon discharge.

Group II: Group A (Antibiotic) Active Control 1 Intervention

Group A will receive postoperative oral antibiotics for 10 - 14 days (Clindamycin or Augmentin) upon discharge.

Who Is Running the Clinical Trial?

Our Lady of the Lake Hospital

Lead Sponsor

Trials

15

Recruited

900+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+