Trial | NCT03333408  Report issue

Official Title

Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    40
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 Started
Jun 15
2018
Primary Completion
Dec 31
2024
Anticipated
Study Completion
Dec 31
2024
Anticipated
Last Update
Nov 01
2023

Drug Postoperative Oral Antibiotics (Clindamycin or Augmentin) [clindamycin (cleocin), amoxicillin, clavulanate (Augmentin)]

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

Group A (Antibiotic) Active Comparator

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

Group B (no Antibiotic) No Intervention

Group B will not be given postoperative oral antibiotics upon discharge.

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
No Results Posted