Clinical trial NCT03333408: Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement
Official title: Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Salivary Duct
Lead sponsor: Our Lady of the Lake Hospital
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2017-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Post-operative infection
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
Study officials:
affiliation: Our Lady of the Lake Hospital
name: Rohan Walvekar, M.D.
role: PRINCIPAL_INVESTIGATOR
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