Salivary Duct
Conditions
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.
Interventions
DRUGPostoperative Oral Antibiotics (Clindamycin or Augmentin)
Patients will receive postoperative oral antibiotics (Clindamycin or Augmentin) for 10-14 days upon discharge.
Sponsors
Louisiana State University Health Sciences Center in New Orleans
Our Lady of the Lake Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative infection | 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. |
Countries
United States
Contacts
Primary ContactRohan Walvekar, M.D.
Backup ContactLeslie Son, Ph.D.
Outcome results
None listed