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Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement

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ClinicalTrials.gov Identifier: NCT03333408
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
Our Lady of the Lake Hospital

Brief Summary:
Salivary duct stent placement is a common practice to maintain duct patency after salivary duct repair or interventional sialendoscopy; 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 sialendoscopy 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.

Condition or disease Intervention/treatment Phase
Salivary Duct Drug: Postoperative Oral Antibiotics (Clindamycin or Augmentin) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019


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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333408


Contacts
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Contact: Rohan Walvekar, M.D. 225-765-1765 rwalve@lsuhsc.edu
Contact: Leslie Son, Ph.D. 225-757-4165 lson@lsuhsc.edu

Locations
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United States, Louisiana
Our Lady of the Lake Regional Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Christine LeBoeuf, DNP    225-765-5956    christine.leboeuf@fmolhs.org   
Sponsors and Collaborators
Our Lady of the Lake Hospital
Louisiana State University Health Sciences Center in New Orleans
Investigators
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Principal Investigator: Rohan Walvekar, M.D. Our Lady of the Lake Regional Medical Center

Publications:

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Responsible Party: Our Lady of the Lake Hospital
ClinicalTrials.gov Identifier: NCT03333408     History of Changes
Other Study ID Numbers: LSUHSC-IRB 9908
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors