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Antibiotic Prophylaxis in Rhinoplasty

Primary Purpose

Nasal Obstruction, Nasal Surgical Procedures

Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.
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
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Obstruction focused on measuring Rhinoplasty, Antibiotic prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Facial Plastic and Reconstructive Surgery Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment arm A

Treatment arm B

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Postoperative Infection Rate
Postoperatively, infection rates between treatment arms will be compared

Secondary Outcome Measures

Full Information

First Posted
December 9, 2019
Last Updated
October 26, 2022
Sponsor
Stanford University
Collaborators
Washington University School of Medicine, Vanderbilt University School of Medicine, University of Washington, Duke University, Harvard University, University of Kansas Medical Center, University of Cincinnati, Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT04194216
Brief Title
Antibiotic Prophylaxis in Rhinoplasty
Official Title
Comparison of Outcomes in Rhinoplasty With the Use of Intraoperative Versus Postoperative Antibiotics
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
April 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Washington University School of Medicine, Vanderbilt University School of Medicine, University of Washington, Duke University, Harvard University, University of Kansas Medical Center, University of Cincinnati, Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction, Nasal Surgical Procedures
Keywords
Rhinoplasty, Antibiotic prophylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Applicable Clinical Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
864 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm A
Arm Type
Active Comparator
Arm Description
Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.
Arm Title
Treatment arm B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.
Other Intervention Name(s)
kelfex (cephalexin), cleocin (clindamycin)
Intervention Description
Treatment Arm A
Intervention Type
Drug
Intervention Name(s)
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
Other Intervention Name(s)
kelfex (cephalexin), cleocin (clindamycin)
Intervention Description
Treatment Arm B
Primary Outcome Measure Information:
Title
Postoperative Infection Rate
Description
Postoperatively, infection rates between treatment arms will be compared
Time Frame
Seven days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam P Most, MD
Organizational Affiliation
Stanford Facial Plastic and Reconstructive Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facial Plastic and Reconstructive Surgery Clinic
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30489601
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.
Results Reference
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PubMed Identifier
28145848
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.
Results Reference
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PubMed Identifier
31647506
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.
Results Reference
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Antibiotic Prophylaxis in Rhinoplasty

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