Antibiotic Prophylaxis in Rhinoplasty

Nasal Obstruction Clinical Trial

Official title:

Comparison of Outcomes in Rhinoplasty With the Use of Intraoperative Versus Postoperative Antibiotics

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04194216
• Other study ID #: 53854
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: May 20, 2020
• Est. completion date: April 20, 2025

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 864
• Est. completion date: April 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasal Obstruction
• Nasal Surgical Procedures

Intervention

Drug:
• Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.
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
Treatment Arm B

Locations

Country	Name	City	State
United States	Facial Plastic and Reconstructive Surgery Clinic	Stanford	California

Sponsors (9)

Lead Sponsor	Collaborator
Stanford University	Duke University, Harvard University, Loma Linda University, University of Cincinnati, University of Kansas Medical Center, University of Washington, Vanderbilt University School of Medicine, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Infection Rate	Postoperatively, infection rates between treatment arms will be compared	Seven days