Nasal ObstructionPhase 3NCT04194216
Antibiotic Prophylaxis in Rhinoplasty
A Phase 3 study testing Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg. and 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 in people with Nasal Obstruction and Nasal Surgical Procedures, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Obstruction, Nasal Surgical Procedures
- What is being tested?
- Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg. and 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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2020to 20 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged 18years and older)
Who cannot join
- Prior rhinoplasty
- Any exogenous (non-nasal) grafts/implants
- Immune deficiency (DM, meds, other)
- History of radiotherapy to nose
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Facial Plastic and Reconstructive Surgery Clinic
Stanford, California, 94305
About this study
Official title: Comparison of Outcomes in Rhinoplasty With the Use of Intraoperative Versus Postoperative Antibiotics
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.
Read the 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.
- Conditions
- Nasal Obstruction, Nasal Surgical Procedures
- Being tested
- 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
- Keywords
- Rhinoplasty, Antibiotic prophylaxis
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.Drug
Also called kelfex (cephalexin), cleocin (clindamycin)
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 daysDrug
Also called kelfex (cephalexin), cleocin (clindamycin)
Treatment Arm B
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm A | Active comparator | Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg. Receives: Drug: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg. |
| Treatment arm B | Active comparator | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Infection Rate
Postoperatively, infection rates between treatment arms will be compared
Measured: Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start20 May 2020
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Applicable Clinical Trial
- Masking
- None (open label)
- Enrolment
- 864 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Sam P. Most, Stanford University
- Investigators
- Sam P Most, MD, Principal investigator, Stanford Facial Plastic and Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194216
- Sponsor's protocol ID
- 53854
- Status last verified
- Apr 2025
- First submitted
- 9 Dec 2019
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30489601Ishii 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.
PubMed 28145848Olds 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.
PubMed 31647506
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes in Rhinoplasty With the Use of Intraoperative Versus Postoperative Antibiotics
- ClinicalTrials.gov ID
- NCT04194216
- Acronym / sponsor ID
- 53854
- Conditions
- Nasal Obstruction, Nasal Surgical Procedures
- Keywords
- Rhinoplasty, Antibiotic prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 864 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- 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
- Study start
- 20 May 2020 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Applicable Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment arm A | Active comparator | Drug: 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. |
| Treatment arm B | Active comparator | 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 daysIntra-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (aged 18years and older)
Key exclusion criteria (4 listed)
- Prior rhinoplasty
- Any exogenous (non-nasal) grafts/implants
- Immune deficiency (DM, meds, other)
- History of radiotherapy to nose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.Also: kelfex (cephalexin), cleocin (clindamycin)Treatment Arm A | Drug | 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 daysAlso: kelfex (cephalexin), cleocin (clindamycin)Treatment Arm B | Drug | Treatment arm B |
Primary outcome
Postoperative Infection Rate
Time frame: Seven days
Postoperatively, infection rates between treatment arms will be compared
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 30489601Nuyen 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: PubMed 28145848Ishii 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: PubMed 31647506Olds 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.
- Individual participant dataSharing planned: No
Related trials for Nasal Obstruction
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
Recruiting
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Nasal Obstruction Due to Inferior Turbinate Hypertrophy
Not yet recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
Not yet recruiting
Comparison Between Turbinoplasty Techniques in Chronic Nasal Obstruction Microdebrider Coblation andSubmucosalBipolarDiathermyTechniquesduetohypertrophoidturbinate
Chronic Nasal Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sam P Most, MD principal investigator
Stanford Facial Plastic and Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg. and 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 in people with Nasal Obstruction and Nasal Surgical Procedures, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Infection Rate (time frame: Seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194216, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.