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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

Be older than 18 years old

Must not have

Prior rhinoplasty

Immune deficiency (DM, meds, other)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up seven days

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had nose surgery before.

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I have a condition or take medication that weakens my immune system.

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I have had radiation therapy on my nose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ seven days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative Infection Rate

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met