drugset / Trial / NCT04194216
Antibiotic Prophylaxis in Rhinoplasty
Phase 3
Enrolling by invitation
864 enrolled
Stanford University
Duke University · collabHarvard University · collabLoma Linda University · collabUniversity of Cincinnati · collabUniversity of Kansas Medical Center · collabUniversity of Washington · collabVanderbilt University School of Medicine · collabWashington University School of Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-05-20
- Primary completion
- 2026-12-20
- Completion
- 2027-04-20
Publications
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CEPHALEXIN ANHYDROUS | Small molecule | 250 mg | Intravenous |
| Comparator | CEPHALEXIN ANHYDROUS | Small molecule | 2 g | Intravenous |
| Comparator | Clindamycin | Unknown | 150 mg | Intravenous |
| Comparator | Clindamycin | Unknown | 900 mg | Intravenous |