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OpenTrials
Enrolling by invitation

NCT Number: NCT04194216

Antibiotic Prophylaxis in Rhinoplasty

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.

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Key information

Conditions

Nasal Obstruction Airway Obstruction Nasal Surgical Procedures Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Facial Plastic and Reconstructive Surgery Clinic

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Treatment Arm A

Other names: kelfex (cephalexin), cleocin (clindamycin)

Intra-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

Drug

Treatment Arm B

Other names: kelfex (cephalexin), cleocin (clindamycin)

Primary outcomes

  1. Postoperative Infection Rate

    Time frame: Seven days

    Postoperatively, infection rates between treatment arms will be compared

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Duke University
  • Harvard University
  • Loma Linda University
  • University of Cincinnati
  • University of Kansas Medical Center
  • University of Washington
  • Vanderbilt University School of Medicine
  • Washington University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Dec 11, 2019
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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