Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement
NCT ID: NCT03333408
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2018-06-15
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A (Antibiotic)
Group A will receive postoperative oral antibiotics for 10 - 14 days (Clindamycin or Augmentin) upon discharge.
Postoperative Oral Antibiotics (Clindamycin or Augmentin)
Patients will receive postoperative oral antibiotics (Clindamycin or Augmentin) for 10-14 days upon discharge.
Group B (no Antibiotic)
Group B will not be given postoperative oral antibiotics upon discharge.
No interventions assigned to this group
Interventions
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Postoperative Oral Antibiotics (Clindamycin or Augmentin)
Patients will receive postoperative oral antibiotics (Clindamycin or Augmentin) for 10-14 days upon discharge.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Louisiana State University Health Sciences Center in New Orleans
OTHER
Our Lady of the Lake Hospital
OTHER
Responsible Party
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Principal Investigators
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Rohan Walvekar, M.D.
Role: PRINCIPAL_INVESTIGATOR
Our Lady of the Lake Hospital
Locations
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Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Lang MS, Gonzalez ML, Dodson TB. Do Antibiotics Decrease the Risk of Inflammatory Complications After Third Molar Removal in Community Practices? J Oral Maxillofac Surg. 2017 Feb;75(2):249-255. doi: 10.1016/j.joms.2016.09.044. Epub 2016 Oct 6.
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.
Fleming-Dutra KE, Hersh AL, Shapiro DJ, Bartoces M, Enns EA, File TM Jr, Finkelstein JA, Gerber JS, Hyun DY, Linder JA, Lynfield R, Margolis DJ, May LS, Merenstein D, Metlay JP, Newland JG, Piccirillo JF, Roberts RM, Sanchez GV, Suda KJ, Thomas A, Woo TM, Zetts RM, Hicks LA. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016 May 3;315(17):1864-73. doi: 10.1001/jama.2016.4151.
Dhiwakar M, Clement WA, Supriya M, McKerrow W. Antibiotics to reduce post-tonsillectomy morbidity. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD005607. doi: 10.1002/14651858.CD005607.pub4.
Aljfout Q, Alississ A, Rashdan H, Maita A, Saraireh M. Antibiotics for Post-Tonsillectomy Morbidity: Comparative Analysis of a Single Institutional Experience. J Clin Med Res. 2016 May;8(5):385-8. doi: 10.14740/jocmr2523w. Epub 2016 Mar 20.
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.
Chen S, Le CH, Liang J. Practice patterns in endoscopic dacryocystorhinostomy: survey of the American Rhinologic Society. Int Forum Allergy Rhinol. 2016 Sep;6(9):990-7. doi: 10.1002/alr.21759. Epub 2016 Apr 6.
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.
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.
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.
Other Identifiers
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LSUHSC-IRB 9908
Identifier Type: -
Identifier Source: org_study_id
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