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By invitation only Phase 3 NCT04194216

Antibiotic Prophylaxis in Rhinoplasty

Phase 3 – large-scale trial before approval
Conditions: Nasal Obstruction Nasal Surgical Procedures

Sponsor: Stanford University

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
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
DRUG
Locations 1
United States (1)
Facial Plastic and Reconstructive Surgery Clinic
Stanford , California
Technical details
Status
By invitation only
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.05.2020
Completion date
20.04.2027
Registry ID
NCT04194216
Source
clinicaltrials.gov
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