Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement

NCT03333408 | Unknown Phase 4 FDA Drug

• 1 other identifier: LSUHSC-IRB 9908
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Post-operative infection

  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.

  2 weeks

Study Arms (2)

Group A (Antibiotic)

ACTIVE COMPARATOR

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

Drug: Postoperative Oral Antibiotics (Clindamycin or Augmentin)

Group B (no Antibiotic)

NO INTERVENTION

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

Interventions

Postoperative Oral Antibiotics (Clindamycin or Augmentin) DRUG

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

Group A (Antibiotic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Our Lady of the Lake Hospital: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 28341449 BACKGROUND

• 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.

  PMID: 28823889 BACKGROUND

• 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.

  PMID: 27139059 BACKGROUND

• 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.

  PMID: 23235625 BACKGROUND

• 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.

  PMID: 27081424 BACKGROUND

• 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.

  PMID: 25140644 BACKGROUND

• 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.

  PMID: 27060784 BACKGROUND

• 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.

  PMID: 28807835 BACKGROUND

• 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.

  PMID: 27761778 BACKGROUND

• 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.

  PMID: 28702309 BACKGROUND

• 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.

  PMID: 18694343 BACKGROUND

MeSH Terms

Interventions

Clindamycin; Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Rohan Walvekar, M.D.

  Our Lady of the Lake Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rohan Walvekar, M.D.

CONTACT

225-765-1765; rwalve@lsuhsc.edu

Leslie Son, Ph.D.

CONTACT

225-757-4165; lson@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 6, 2017
• Study Start: June 15, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)