Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement

October 31, 2023 updated by: Our Lady of the Lake Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Leslie Son, Ph.D.
  • Phone Number: 225-757-4165
  • Email: lson@lsuhsc.edu

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of the Lake Regional Medical Center
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (Antibiotic)
Group A will receive postoperative oral antibiotics for 10 - 14 days (Clindamycin or Augmentin) upon discharge.
Drug: Postoperative Oral Antibiotics (Clindamycin or Augmentin)
Patients will receive postoperative oral antibiotics (Clindamycin or Augmentin) for 10-14 days upon discharge.
No Intervention: Group B (no Antibiotic)
Group B will not be given postoperative oral antibiotics upon discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative infection
Time Frame: 2 weeks
The primary endpoint will be the determination of clinical infection between the time points post-operation to the 2 week follow-up visit when the stent is removed as indicated by evidence of purulence or erythema at the surgical site, fever and elevated white blood cell count.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Our Lady of the Lake Hospital

Collaborators

Louisiana State University Health Sciences Center in New Orleans

Investigators

  • Principal Investigator: Rohan Walvekar, M.D., Our Lady of the Lake Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSUHSC-IRB 9908

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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