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Antibiotic Prophylaxis in Rhinoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194216
Recruitment Status : Not yet recruiting
First Posted : December 11, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborators:
Washington University School of Medicine
Université de Montréal
Information provided by (Responsible Party):
Sam P. Most, Stanford University

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.

Condition or disease Intervention/treatment Phase
Nasal Obstruction Nasal Surgical Procedures Drug: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg. Drug: 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 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Applicable Clinical Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Outcomes in Rhinoplasty With the Use of Intraoperative Versus Postoperative Antibiotics
Estimated Study Start Date : January 20, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : April 20, 2024


Arm Intervention/treatment
Active Comparator: Treatment arm A
Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.
Drug: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.
Treatment Arm A
Other Names:
  • Kelfex (cephalexin)
  • Cleocin (clindamycin)

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.
Drug: 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
Other Names:
  • Kelfex (cephalexin)
  • Cleocin (clindamycin)




Primary Outcome Measures :
  1. Postoperative Infection Rate [ Time Frame: Seven days ]
    Postoperatively, infection rates between treatment arms will be compared



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194216


Contacts
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Contact: Sam P Most, MD 6507363223 smost@stanford.edu
Contact: Cherian K Kandathil, MD 6507216000 ckandathil@stanford.edu

Locations
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United States, California
Facial Plastic and Reconstructive Surgery Clinic
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Washington University School of Medicine
Université de Montréal
Investigators
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Principal Investigator: Sam P Most, MD Stanford Facial Plastic and Reconstructive Surgery

Publications:
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Responsible Party: Sam P. Most, Professor and Chief, Division of Facial Plastic and Reconstructive Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT04194216    
Other Study ID Numbers: 53854
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sam P. Most, Stanford University:
Rhinoplasty
Antibiotic prophylaxis
Additional relevant MeSH terms:
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Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Cephalexin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action