Clinical trial NCT04194216: Antibiotic Prophylaxis in Rhinoplasty
Official title: Comparison of Outcomes in Rhinoplasty With the Use of Intraoperative Versus Postoperative Antibiotics
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Nasal Obstruction
Nasal Surgical Procedures
Keywords: Rhinoplasty
Antibiotic prophylaxis
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: Vanderbilt University School of Medicine
name: University of Washington
name: Duke University
name: Harvard University
name: University of Kansas Medical Center
name: University of Cincinnati
name: Loma Linda University
First posted: 2019-12-11
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Applicable Clinical Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Infection Rate
timeFrame: Seven days
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Facial Plastic and Reconstructive Surgery Clinic
state: California
Study officials:
affiliation: Stanford Facial Plastic and Reconstructive Surgery
name: Sam P Most, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.