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Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement

NCT03333408 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-01

No results posted yet for this study

Summary

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.

Conditions

  • Salivary Duct

Interventions

DRUG

Postoperative Oral Antibiotics (Clindamycin or Augmentin)

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

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

    collaborator OTHER

  • Our Lady of the Lake Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333408 on ClinicalTrials.gov