Antibiotic Prophylaxis in Rhinoplasty

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nasal Obstruction; Nasal Surgical Procedures
• Intervention / Treatment: Drug: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.; 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 864
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Facial Plastic and Reconstructive Surgery Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Treatment Arm A; Other Names: kelfex (cephalexin); cleocin (clindamycin)
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; Treatment Arm B; Other Names: kelfex (cephalexin); cleocin (clindamycin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Infection Rate	Postoperatively, infection rates between treatment arms will be compared	Seven days

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Washington University School of Medicine; Duke University; University of Washington; University of Kansas Medical Center; Loma Linda University; University of Cincinnati; Harvard University; Vanderbilt University School of Medicine
• Investigators: Principal Investigator: Sam P Most, MD, Stanford Facial Plastic and Reconstructive Surgery

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): April 20, 2025

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Antibiotic prophylaxis; Rhinoplasty
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cephalexin
• Other Study ID Numbers: 53854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes