Postoperative Antibiotics for Salivary Duct Procedures
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether antibiotics are necessary after salivary duct surgery to prevent infections. Researchers compare two groups: one receives antibiotics like Clindamycin or Augmentin for 10-14 days post-surgery, while the other does not. The study aims to determine if the potential side effects of antibiotics, such as stomach issues and antibiotic resistance, outweigh their benefits in infection prevention. It suits adults undergoing salivary duct surgery with stent placement at Our Lady of the Lake Regional Medical Center who agree to be randomly assigned to receive or not receive antibiotics after surgery. As a Phase 4 trial, it involves treatments already FDA-approved and proven effective, helping to understand their benefits for more patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for Augmentin and Clindamycin?
Research shows that both Clindamycin and Augmentin have safety concerns to consider. Studies have found that Clindamycin may significantly increase the risk of infections at surgical sites, with one study noting about a fourfold increase in risk. Clindamycin might also be less effective in preventing infections after some dental surgeries and could have negative effects.
In contrast, Augmentin (Amoxicillin/Clavulanate) is generally well-tolerated. Research indicates no significant complications during or after surgery for patients taking Augmentin for similar procedures. It is often used as a standard treatment for injuries and has a good safety record in these situations.
In summary, while Augmentin seems to have a strong safety profile, Clindamycin presents some risks that should be carefully considered. Always consult a healthcare provider to determine the best option.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about this trial because it explores the necessity of postoperative antibiotics following salivary duct procedures. Traditionally, antibiotics like Augmentin and Clindamycin are prescribed to prevent infections after surgery. However, this trial is investigating whether withholding antibiotics is just as effective, which could reduce unnecessary antibiotic use and help prevent antibiotic resistance. By comparing patients who receive antibiotics to those who don't, researchers hope to determine the true necessity of these medications in postoperative care.
What evidence suggests that this trial's treatments could be effective for postoperative salivary duct procedures?
In this trial, participants in Group A will receive postoperative oral antibiotics, either Clindamycin or Augmentin, for 10-14 days upon discharge. Research has shown that Augmentin, a combination of amoxicillin and clavulanic acid, helps prevent infections after oral surgeries. Specifically, those taking Augmentin experienced less bad breath, resumed eating normal food sooner, and returned to daily activities more quickly. In contrast, results for Clindamycin are mixed. Some studies indicate it lowers infection risk, while others found it might increase the chance of infections at the surgery site. Overall, Augmentin has more reliable support for preventing infections after surgery compared to Clindamycin. Participants in Group B will not receive postoperative oral antibiotics.36789
Who Is on the Research Team?
Rohan Walvekar, M.D.
Principal Investigator
Our Lady of the Lake Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo salivary duct stent placement and receive perioperative antibiotics. Group A receives postoperative oral antibiotics for 10-14 days, while Group B does not receive postoperative antibiotics.
Follow-up
Participants are monitored for post-operative infection and other adverse events. The primary endpoint is assessed at the 2-week follow-up visit when the stent is removed.
What Are the Treatments Tested in This Trial?
Interventions
- Augmentin
- Clindamycin
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Active Control
Group B will not be given postoperative oral antibiotics upon discharge.
Group A will receive postoperative oral antibiotics for 10 - 14 days (Clindamycin or Augmentin) upon discharge.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Our Lady of the Lake Hospital
Lead Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborator
Citations
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The combination of amoxicillin and clavulanic has proven to be significantly more effective in comparison with the use of amoxicillin after oral-surgical ...
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Specifically, patients in the antibiotic group experienced significantly less mouth odor, were able to tolerate a regular diet sooner, and resumed their normal ...
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(PDF) Efficacy of amoxicillin and amoxicillin/clavulanic acid ...
Single drug therapy with the amoxicillin-clavulanic acid was used in 22 patients (group A). The other 22 patients (group B) were given a ...
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The drug of choice is amoxicillin/clavulanate potassium (Augmentin; adult dosage 500/125 mg PO tid or 875/125 mg PO bid). It is the most ...
Simplifying Submandibular Duct Sialolith Removal Using ...
No intra- and post-operative complications were detected. Preprints 114689 g006. Figure 6. Detail of the removed calculus. Postoperatively, ...
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