Study Summary
This trial examines the efficacy of postoperative antibiotics following salivary duct stent placement.
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 2 weeks
2 weeks
Communicable Diseases
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Group A (Antibiotic)
1 of 2
Group B (no Antibiotic)
1 of 2
Active Control
40 Total Participants · 2 Treatment Groups
Primary Treatment: Group A (Antibiotic) · No Placebo Group · Phase 4
Group A (Antibiotic)
Drug
ActiveComparator Group · 1 Intervention: Postoperative Oral Antibiotics (Clindamycin or Augmentin) · Intervention Types: DrugGroup B (no Antibiotic)NoIntervention Group · 1 Intervention: Group B (no Antibiotic) · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks
Who is running the clinical trial?
Louisiana State University Health Sciences Center in New OrleansOTHER
104 Previous Clinical Trials
41,232 Total Patients Enrolled
Our Lady of the Lake HospitalLead Sponsor
5 Previous Clinical Trials
230 Total Patients Enrolled
Rohan Walvekar, M.D.Principal InvestigatorOur Lady of the Lake Regional Medical Center
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- 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.
- 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.
- 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.
- Araujo da Silva, A.R., D.C. Albernaz de Almeida Dias, A.F. Marques, C. Biscaia di Biase, I.K. Murni, A. Dramowski, M. Sharland, J. Huebner, and W. Zingg. 2018. “Role of Antimicrobial Stewardship Programmes in Children: A Systematic Review”. Journal of Hospital Infection. Elsevier BV. doi:10.1016/j.jhin.2017.08.003.
- Linder, Jeffrey A.. 2008. “editorial Commentary:antibiotics for Treatment of Acute Respiratory Tract Infections: Decreasing Benefit, Increasing Risk, and the Irrelevance of Antimicrobial Resistance”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1086/591149.
- Taub, Daniel, Andrew Yampolsky, Robert Diecidue, and Lionel Gold. 2017. “Controversies in the Management of Oral and Maxillofacial Infections”. Oral and Maxillofacial Surgery Clinics of North America. Elsevier BV. doi:10.1016/j.coms.2017.06.004.
- Santana, Rafael Santos, Ariane de Carvalho Viana, Jozimário da Silva Santiago, Michelle Santos Menezes, Iza Maria Fraga Lobo, and Paulo Sergio Marcellini. 2014. “The Cost of Excessive Postoperative Use of Antimicrobials: The Context of a Public Hospital”. Revista Do Colégio Brasileiro De Cirurgiões. FapUNIFESP (SciELO). doi:10.1590/s0100-69912014000300003.
- Phuong, Nguyen T. K., Tran T. Hoang, Pham H. Van, Lolyta Tu, Stephen M. Graham, and Ben J. Marais. 2017. “Encouraging Rational Antibiotic Use in Childhood Pneumonia: A Focus on Vietnam and the Western Pacific Region”. Pneumonia. Springer Science and Business Media LLC. doi:10.1186/s41479-017-0031-4.
- Chen, Sonia, Christopher H. Le, and Jonathan Liang. 2016. “Practice Patterns in Endoscopic Dacryocystorhinostomy: Survey of the American Rhinologic Society”. International Forum of Allergy & Rhinology. Wiley. doi:10.1002/alr.21759.
- Stultz, Jeremy S., Christopher D. Doern, and Emily Godbout. 2016. “Antibiotic Resistance in Pediatric Urinary Tract Infections”. Current Infectious Disease Reports. Springer Science and Business Media LLC. doi:10.1007/s11908-016-0555-4.
- Dhiwakar, Muthuswamy, W A Clement, Mrinal Supriya, and William McKerrow. 2012. “Antibiotics to Reduce Post-tonsillectomy Morbidity”. Edited by Muthuswamy Dhiwakar. Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd. doi:10.1002/14651858.cd005607.pub4.
- 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.
- Stultz JS, Doern CD, Godbout E. Antibiotic Resistance in Pediatric Urinary Tract Infections. Curr Infect Dis Rep. 2016 Dec;18(12):40. doi: 10.1007/s11908-016-0555-4.
- Taub D, Yampolsky A, Diecidue R, Gold L. Controversies in the Management of Oral and Maxillofacial Infections. Oral Maxillofac Surg Clin North Am. 2017 Nov;29(4):465-473. doi: 10.1016/j.coms.2017.06.004. Epub 2017 Aug 18.
- Dhiwakar M, Clement WA, Supriya M, McKerrow W. Antibiotics to reduce post-tonsillectomy morbidity. Cochrane Database Syst Rev. 2012 Dec 12;12:CD005607. doi: 10.1002/14651858.CD005607.pub4.
- Phuong NTK, Hoang TT, Van PH, Tu L, Graham SM, Marais BJ. Encouraging rational antibiotic use in childhood pneumonia: a focus on Vietnam and the Western Pacific Region. Pneumonia (Nathan). 2017 Apr 25;9:7. doi: 10.1186/s41479-017-0031-4. eCollection 2017.
- Linder JA. Editorial commentary: antibiotics for treatment of acute respiratory tract infections: decreasing benefit, increasing risk, and the irrelevance of antimicrobial resistance. Clin Infect Dis. 2008 Sep 15;47(6):744-6. doi: 10.1086/591149. No abstract available.
- Araujo da Silva AR, Albernaz de Almeida Dias DC, Marques AF, Biscaia di Biase C, Murni IK, Dramowski A, Sharland M, Huebner J, Zingg W. Role of antimicrobial stewardship programmes in children: a systematic review. J Hosp Infect. 2018 Jun;99(2):117-123. doi: 10.1016/j.jhin.2017.08.003. Epub 2017 Aug 12.
- Santana RS, Viana Ade C, Santiago Jda S, Menezes MS, Lobo IM, Marcellini PS. The cost of excessive postoperative use of antimicrobials: the context of a public hospital. Rev Col Bras Cir. 2014 May-Jun;41(3):149-54. doi: 10.1590/s0100-69912014000300003. English, Portuguese.
- 2018. "Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03333408.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer