Antibiotic Prophylaxis in Rhinoplasty

NCT04194216 | Enrolling By Invitation Phase 3 FDA Drug

• 1 other identifier: 53854
• Study Type: interventional
• Target: 864
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Obstruction; Nasal Surgical Procedures

Keywords

Rhinoplasty; Antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• Postoperative Infection Rate

  Postoperatively, infection rates between treatment arms will be compared

  Seven days

Study Arms (2)

Treatment arm A

ACTIVE COMPARATOR

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.

Treatment arm B

ACTIVE COMPARATOR

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

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

Treatment Arm A

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

Treatment arm A

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

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

Treatment arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (aged 18years and older)

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Washington University School of Medicine: collaborator
• University of Washington: collaborator
• Vanderbilt University School of Medicine: collaborator
• Duke University: collaborator
• Harvard University: collaborator
• University of Kansas Medical Center: collaborator
• University of Cincinnati: collaborator
• Loma Linda University: collaborator

Study Sites (1)

Facial Plastic and Reconstructive Surgery Clinic

Stanford, California, 94305, United States

Location

Related Publications (3)

• 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.

  PMID: 30489601 BACKGROUND

• 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.

  PMID: 28145848 BACKGROUND

• 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.

  PMID: 31647506 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Clindamycin; Cephalexin

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sam P Most, MD

  Stanford Facial Plastic and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief, Division of Facial Plastic and Reconstructive Surgery

Model Details: Applicable Clinical Trial

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: May 20, 2020
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): April 20, 2027
• Last Updated: April 24, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)