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Salivary DuctPhase 4NCT03333408

Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement

A Phase 4 study testing Postoperative Oral Antibiotics (Clindamycin or Augmentin) in people with Salivary Duct, run by Our Lady of the Lake Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Salivary Duct
What is being tested?
Postoperative Oral Antibiotics (Clindamycin or Augmentin)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
15 Jun 2018to 31 Dec 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Rohan Walvekar, M.D. contact

225-765-1765

rwalve@lsuhsc.edu

Leslie Son, Ph.D. contact

225-757-4165

lson@lsuhsc.edu

United States1 site, 1 recruiting

  • Our Lady of the Lake Regional Medical Center

    Baton Rouge, Louisiana, 70808

    Christine LeBoeuf, DNP, 225-765-5956, christine.leboeuf@fmolhs.org

    Recruiting

Other trials in United States

About this study

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
Being tested
Postoperative Oral Antibiotics (Clindamycin or Augmentin)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Postoperative Oral Antibiotics (Clindamycin or Augmentin)Drug

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

Study groups in NCT03333408
Study groupRoleWhat they receive
Group A (Antibiotic)Active comparatorGroup A will receive postoperative oral antibiotics for 10 - 14 days (Clindamycin or Augmentin) upon discharge.
Receives: Drug: Postoperative Oral Antibiotics (Clindamycin or Augmentin)
Group B (no Antibiotic)No interventionGroup B will not be given postoperative oral antibiotics upon discharge.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start15 Jun 2018
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03333408
Sponsor's protocol ID
LSUHSC-IRB 9908
Status last verified
Oct 2023
First submitted
20 Oct 2017
Last updated
1 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28341449

  • 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.

    PubMed 28823889

  • 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.

    PubMed 27139059

  • 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.

    PubMed 23235625

  • 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.

    PubMed 27081424

  • 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.

    PubMed 25140644

  • 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.

    PubMed 27060784

  • 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.

    PubMed 28807835

  • 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.

    PubMed 27761778

  • 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.

    PubMed 28702309

  • 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.

    PubMed 18694343

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Postoperative Oral Antibiotics (Clindamycin or Augmentin) in people with Salivary Duct, run by Our Lady of the Lake Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rohan Walvekar, M.D. (225-765-1765, rwalve@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative infection (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03333408, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.

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