Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement

Phase 4

Recruiting

• Conditions: Salivary Duct
• Interventions: Drug: Postoperative Oral Antibiotics (Clindamycin or Augmentin)

• Registration Number: NCT03333408
• Lead Sponsor: 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Study Start: 2018-06-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Antibiotic)	Postoperative Oral Antibiotics (Clindamycin or Augmentin)	Group A will receive postoperative oral antibiotics for 10 - 14 days (Clindamycin or Augmentin) upon discharge.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Our Lady of the Lake Regional Medical Center; 🇺🇸 Baton Rouge, Louisiana, United States