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Antibiotic Prophylaxis in Rhinoplasty

Comparison of Outcomes in Rhinoplasty With the Use of Intraoperative Versus Postoperative Antibiotics

Status
Enrolling by invitation
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04194216
Enrollment
864
Registered
2019-12-11
Start date
2020-05-20
Completion date
2027-04-20
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Obstruction, Nasal Surgical Procedures

Keywords

Rhinoplasty, Antibiotic prophylaxis

Brief summary

This study compares the efficacy of a single intra-operative (intravenous) dose of "cephalexin" (first generation cephalosporin) or "clindamycin" (lincosamides), alone versus both intra-operative (intravenous) dose of "cephalexin" (first generation cephalosporin) or "clindamycin" (lincosamides) and postoperative oral dose of "cephalexin" or "clindamycin" use in nasal surgery.

Detailed description

The study will consist of 2 treatment arms: Treatment arm A: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg. Treatment arm B: 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.

Interventions

DRUGIntra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.

Treatment Arm A

DRUGIntra-operative single dose (iv) 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 3 days

Treatment Arm B

Sponsors

Stanford University
Lead SponsorOTHER
Washington University School of Medicine
CollaboratorOTHER
Vanderbilt University School of Medicine
CollaboratorOTHER
University of Washington
CollaboratorOTHER
Duke University
CollaboratorOTHER
Harvard University
CollaboratorOTHER
University of Kansas Medical Center
CollaboratorOTHER
University of Cincinnati
CollaboratorOTHER
Loma Linda University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Applicable Clinical Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients (aged 18years and older)

Exclusion criteria

* Prior rhinoplasty * Any exogenous (non-nasal) grafts/implants * Immune deficiency (DM, meds, other) * History of radiotherapy to nose

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Infection RateSeven daysPostoperatively, infection rates between treatment arms will be compared

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSam P Most, MD

Stanford Facial Plastic and Reconstructive Surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026