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Enrolling by invitationNCT04194216Updated Apr 24, 2026

Antibiotic Prophylaxis in Rhinoplasty

A Phase 3 interventional study of Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg. and 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 in Nasal Obstruction and Nasal Surgical Procedures, sponsored by Stanford University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Stanford University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
864
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Nasal Obstruction
  • Nasal Surgical Procedures

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Keywords

  • Rhinoplasty
  • Antibiotic prophylaxis
03

In context

Nasal Obstruction

108 studies on the registry are indexed under Nasal Obstruction; 27 are open to participants now.

This study's planned enrollment of 864 is above the median of 52 across 80 interventional studies indexed under Nasal Obstruction.

Browse Nasal Obstruction studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Adult patients (aged 18years and older)

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
864 participants (estimated)

Study arms

  • Active comparator
    Treatment arm A

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

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

  • Active comparator
    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.

    Drug: 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

Interventions

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

    Treatment Arm A

    Also known as: kelfex (cephalexin), cleocin (clindamycin)

  • 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

    Also known as: kelfex (cephalexin), cleocin (clindamycin)

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What researchers measure

Primary outcomes

  1. Postoperative Infection Rate

    Postoperatively, infection rates between treatment arms will be compared

    Time frame: Seven days

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Study locations

1 site
  • Facial Plastic and Reconstructive Surgery Clinic
    Stanford, California 94305, United States
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References and documents

Publications

  • Nuyen B, Kandathil CK, Laimi K, Rudy SF, Most SP, Saltychev M. Evaluation of Antibiotic Prophylaxis in Rhinoplasty: A Systematic Review and Meta-analysis. JAMA Facial Plast Surg. 2019 Jan 1;21(1):12-17. doi: 10.1001/jamafacial.2018.1187. PubMed 30489601 ↗
  • Ishii LE, Tollefson TT, Basura GJ, Rosenfeld RM, Abramson PJ, Chaiet SR, Davis KS, Doghramji K, Farrior EH, Finestone SA, Ishman SL, Murphy RX Jr, Park JG, Setzen M, Strike DJ, Walsh SA, Warner JP, Nnacheta LC. Clinical Practice Guideline: Improving Nasal Form and Function after Rhinoplasty Executive Summary. Otolaryngol Head Neck Surg. 2017 Feb;156(2):205-219. doi: 10.1177/0194599816683156. PubMed 28145848 ↗
  • Olds C, Spataro E, Li K, Kandathil C, Most SP. Postoperative Antibiotic Use Among Patients Undergoing Functional Facial Plastic and Reconstructive Surgery. JAMA Facial Plast Surg. 2019 Dec 1;21(6):491-497. doi: 10.1001/jamafacial.2019.1027. PubMed 31647506 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04194216
Lead sponsor
Stanford University
Collaborators
Washington University School of Medicine, Vanderbilt University School of Medicine, University of Washington, Duke University, Harvard University, University of Kansas Medical Center, University of Cincinnati, Loma Linda University
Responsible party
Sam P. Most (Professor and Chief, Division of Facial Plastic and Reconstructive Surgery, Stanford University) — Principal investigator
First posted
Dec 11, 2019
Start date
May 20, 2020
Primary completion
Dec 20, 2026 (estimated)
Completion
Apr 20, 2027 (estimated)
Last update
Apr 24, 2026

Study contacts

Sam P Most, MD
principal investigator · Stanford Facial Plastic and Reconstructive Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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