Recruiting

Observational Study

Sponsor:

Our Lady of the Lake Hospital

Code:

NCT03333408

Conditions

Salivary Duct

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Postoperative Oral Antibiotics (Clindamycin or Augmentin)

Study Details

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.

Conditions

Salivary Duct

Study ID

NCT03333408

Start date

Jun 15, 2018

Status verified date

Oct, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A (Antibiotic)

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

no intervention: Group B (no Antibiotic)

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

Interventions

Postoperative Oral Antibiotics (Clindamycin or Augmentin)

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

Primary outcome measure

  • Post-operative infection [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

Our Lady of the Lake Regional Medical Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

More Information

Sponsor

Our Lady of the Lake Hospital

Last update posted

Nov 1, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Our Lady of the Lake Hospital on 2023-11-01.