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Postoperative Antibiotics for Salivary Duct Procedures

Phase 4

Recruiting

Led By Rohan Walvekar, M.D.

Research Sponsored by Our Lady of the Lake Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

Study Summary

This trial examines the efficacy of postoperative antibiotics following salivary duct stent placement.

Who is the study for?

Adults over 18 needing salivary duct surgery and stent placement at Our Lady of the Lake Regional Medical Center can join. Excluded are those unwilling to be randomized, with acute infections, immunocompromised, early stent dislodgement, or who don't finish their antibiotics unless due to side effects.Check my eligibility

What is being tested?

The trial is testing if taking oral antibiotics (Clindamycin or Augmentin) after salivary duct stent placement is necessary. Patients will either receive postoperative antibiotics for 10-14 days or none, to see if avoiding them reduces complications like gastrointestinal issues and antibiotic resistance.See study design

What are the potential side effects?

Potential side effects from Clindamycin or Augmentin include stomach upset, nausea, diarrhea potentially leading to C.diff infection (a serious gut infection), and contributing to antibiotic resistance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult scheduled for salivary duct surgery with stent placement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Communicable Diseases

Trial Design

2Treatment groups

Active Control

Group I: Group B (no Antibiotic)Active Control1 Intervention

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

Group II: Group A (Antibiotic)Active Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansOTHER

114 Previous Clinical Trials

44,161 Total Patients Enrolled

Our Lady of the Lake HospitalLead Sponsor

12 Previous Clinical Trials

799 Total Patients Enrolled

Rohan Walvekar, M.D.Principal InvestigatorOur Lady of the Lake Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is enrollment open for this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this experiment is currently looking for participants that were initially posted on June 15th 2018 and was most recently updated April 20th 2022. This endeavor needs around 40 individuals from one distinct site."

Answered by AI

Are medical centers currently enrolling individuals in this clinical research?

"Affirmative, the information available on clinicaltrials.gov demonstrate that this medical test is currently recruiting patients. This trial was first publicized in June 15th 2018 and has been modified most recently in April 20th 2022. A total of 40 participants are required from one single site for the study to be completed successfully."

Answered by AI

Has Group A (Antibiotic) received regulatory clearance from the FDA?

"There is a wealth of evidence attesting to Group A's (Antibiotic) safety, so it received the highest score possible - 3."

Answered by AI

What do physicians typically prescribe Group A (Antibiotic) to treat?

"Group A (Antibiotic) is typically prescribed to treat bacterial and anaerobic pathogens, such as systemic-pulmonary shunt post-surgery, helicobacter pylori infection, and enterobacter cloacae."

Answered by AI

Recent research and studies

JamaJournal

Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011

Fleming-Dutra, Katherine E., Adam L. Hersh, Daniel J. Shapiro, Monina Bartoces, Eva A. Enns, Thomas M. File Jr, Jonathan A. Finkelstein, et al.. 2016. “Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011”. Jama. American Medical Association (AMA). doi:10.1001/jama.2016.4151.

Journal of Clinical Medicine ResearchJournal

Antibiotics for Post-tonsillectomy Morbidity: Comparative Analysis of a Single Institutional Experience

Aljfout, Qais, Amjad Alississ, Hesham Rashdan, Abdullah Maita, and Mohammad Saraireh. 2016. “Antibiotics for Post-tonsillectomy Morbidity: Comparative Analysis of a Single Institutional Experience”. Journal of Clinical Medicine Research. Elmer Press, Inc.. doi:10.14740/jocmr2523w.

Journal of Oral and Maxillofacial SurgeryJournal

Do Antibiotics Decrease the Risk of Inflammatory Complications After Third Molar Removal in Community Practices?

Lang, Melanie S., Martin L. Gonzalez, and Thomas B. Dodson. 2017. “Do Antibiotics Decrease the Risk of Inflammatory Complications After Third Molar Removal in Community Practices?”. Journal of Oral and Maxillofacial Surgery. Elsevier BV. doi:10.1016/j.joms.2016.09.044.

Journal of Hospital InfectionJournal