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Antibiotic

Antibiotics for Rhinoplasty

Phase 3
Waitlist Available
Led By Sam P Most, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients (aged 18 years and older)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up seven days
Awards & highlights

Study Summary

This trial found that using both an intraoperative dose of either cephalexin or clindamycin, and a postoperative oral dose of either cephalexin or clindamycin, was more effective than using either drug alone in nasal surgery.

Who is the study for?
Adults aged 18 or older who are undergoing nasal surgery can participate. Those with previous rhinoplasty, non-nasal grafts/implants, immune deficiencies (like diabetes or due to medications), or a history of radiotherapy to the nose cannot join.Check my eligibility
What is being tested?
The study is testing if giving an antibiotic called 'cephalexin' or 'clindamycin' just once during surgery is as effective as giving it both during and after surgery for three days in preventing infections after nasal surgery.See study design
What are the potential side effects?
Possible side effects include allergic reactions, stomach upset like diarrhea, nausea, vomiting; and less commonly, severe intestinal condition (Clostridium difficile-associated diarrhea) due to resistant bacteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~seven days
This trial's timeline: 3 weeks for screening, Varies for treatment, and seven days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative Infection Rate

Trial Design

2Treatment groups
Active Control
Group I: Treatment arm BActive Control1 Intervention
Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg and postoperative oral dose of "cephalexin" 250mg every 4 hours or "clindamycin" 150mg every 6 hours, for a duration of three days.
Group II: Treatment arm AActive Control1 Intervention
Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,374 Previous Clinical Trials
17,332,063 Total Patients Enrolled
Washington University School of MedicineOTHER
1,928 Previous Clinical Trials
2,296,224 Total Patients Enrolled
Vanderbilt University School of MedicineOTHER
14 Previous Clinical Trials
12,997 Total Patients Enrolled

Media Library

Cephalexin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04194216 — Phase 3
Nasal Congestion Research Study Groups: Treatment arm B, Treatment arm A
Nasal Congestion Clinical Trial 2023: Cephalexin Highlights & Side Effects. Trial Name: NCT04194216 — Phase 3
Cephalexin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04194216 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there historical precedents for this proposed course of treatment?

"There are currently 28 ongoing clinical trials testing Treatment arm A. Of these, 8 have progressed to Phase 3. The majority of the Vancouver-based clinical trials will soon be completed, however there are 138 locations worldwide still running tests for this treatment option."

Answered by AI

How many people are currently involved in this clinical trial?

"Right now, this study isn't looking for new patients. The listing was created on May 20th, 2020 and updated October 26th, 2022. If you're interested in other studies, there are 18 trials related to nasal surgical procedures and 28 concerning Treatment arm A admitting patients right now."

Answered by AI

What is the FDA's stance on Treatment arm A?

"Treatment arm A of this clinical trial has received a safety score of 3. This is because efficacy has been partially proven in Phase 3 trials and there is supporting data from multiple rounds of testing."

Answered by AI

Are there any unfilled vacancies in this experiment for new participants?

"According to the website clinicaltrials.gov, this study is not presently recruiting patients. This trial was initially posted on May 20th, 2020 and was last updated on October 26th, 2020. Although this particular trial isn't searching for candidates right now, there are 46 other trials that are currently accepting patients."

Answered by AI

What is the purpose of Treatment arm A?

"Treatment arm A is designed to target anaerobic bacteria, but can also be used to fight against acquired valvular dysfunction, surgically constructed systemic-pulmonary shunt, and viridans group streptococci."

Answered by AI
~126 spots leftby Dec 2024