Antibiotic Prophylaxis in Rhinoplasty

NCT ID: NCT04194216

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

864 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2027-04-20

Brief Summary

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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

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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.

Conditions

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Nasal Obstruction Nasal Surgical Procedures

Keywords

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Rhinoplasty Antibiotic prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Applicable Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm A

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Treatment Arm A

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Treatment Arm B

Interventions

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

Treatment Arm A

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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kelfex (cephalexin) cleocin (clindamycin) kelfex (cephalexin) cleocin (clindamycin)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role collaborator

Vanderbilt University School of Medicine

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role collaborator

Loma Linda University

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sam P. Most

Professor and Chief, Division of Facial Plastic and Reconstructive Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sam P Most, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Facial Plastic and Reconstructive Surgery

Locations

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Facial Plastic and Reconstructive Surgery Clinic

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30489601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28145848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31647506 (View on PubMed)

Other Identifiers

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53854

Identifier Type: -

Identifier Source: org_study_id