Antibiotic Prophylaxis in Rhinoplasty

Phase 3

• Conditions: Nasal Obstruction; Nasal Surgical Procedures
• Interventions: 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

• Registration Number: NCT04194216
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Study Start: 2020-05-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2026-12-20
• Study Completion: 2027-04-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 864

Inclusion Criteria

Adult patients (aged 18years and older)

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm A	Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.	Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.
Treatment arm B	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	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Infection Rate	Seven days	Postoperatively, infection rates between treatment arms will be compared

Trial Locations

Locations (1)

Facial Plastic and Reconstructive Surgery Clinic; 🇺🇸 Stanford, California, United States