Antibiotic Prophylaxis in Rhinoplasty

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT04194216
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Nasal Obstruction
  • Nasal Surgical Procedures

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 20, 2020
Status verified
Apr 2025
Primary completion
Dec 20, 2026
Completion
Apr 20, 2027

Study Design

Enrollment
864 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment arm A
    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.

Primary Outcome Measure

Postoperative Infection Rate [ Time Frame: Seven days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Facial Plastic and Reconstructive Surgery ClinicStanfordCalifornia94305-

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