Antibiotics for Rhinoplasty

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Stanford University

Disqualifiers: Prior rhinoplasty, Immune deficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 days

864 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have an immune deficiency due to medications, you may not be eligible to participate.

What data supports the effectiveness of the drug Cephalexin for rhinoplasty?

Cephalexin is effective in treating skin and soft-tissue infections, with cure rates of 90% or higher, making it a reliable option for preventing infections after surgeries like rhinoplasty. ^{1 2 3 4 5}

Is it safe to use antibiotics like Cephalexin and Clindamycin for rhinoplasty?

Cephalexin and Clindamycin are generally considered safe for use in humans, but they can cause allergic reactions in some people, especially those with a history of allergies to similar antibiotics. Clindamycin may also face resistance issues, which could affect its effectiveness in preventing infections. ^{4 6 7 8 9}

How does the drug Cephalexin and Clindamycin differ from other treatments for rhinoplasty?

Cephalexin and Clindamycin are antibiotics used to prevent infections after rhinoplasty, especially in patients with allergies to other antibiotics like penicillin. Clindamycin is often used for those with penicillin allergies, but there is a concern about increased resistance in some bacteria, which makes the combination with Cephalexin potentially more effective in preventing infections. ^{1 4 7 10 11}

Research Team

Sam P Most, MD

Principal Investigator

Stanford Facial Plastic and Reconstructive Surgery

Eligibility Criteria

Adults aged 18 or older who are undergoing nasal surgery can participate. Those with previous rhinoplasty, non-nasal grafts/implants, immune deficiencies (like diabetes or due to medications), or a history of radiotherapy to the nose cannot join.

Inclusion Criteria

I am 18 years old or older.

Exclusion Criteria

You have had any type of surgical implants or grafts other than in the nose.

I have had radiation therapy on my nose.

I have had nose surgery before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a single intra-operative intravenous dose of cephalexin or clindamycin, with or without additional postoperative oral doses for three days

3 days

Follow-up

Participants are monitored for postoperative infection rates

7 days

Treatment Details

Interventions

• Cephalexin
• Clindamycin

Trial Overview The study is testing if giving an antibiotic called 'cephalexin' or 'clindamycin' just once during surgery is as effective as giving it both during and after surgery for three days in preventing infections after nasal surgery.

Participant Groups

Group I: Treatment arm B Active Control 1 Intervention

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 II: Treatment arm A Active Control 1 Intervention

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

Cephalexin is already approved in United States, European Union, Canada, Switzerland for the following indications:

Approved in United States as Keflex for:

• Respiratory tract infections
• Otitis media
• Skin and skin structure infections
• Bone infections
• Genitourinary tract infections

Approved in European Union as Cefalexin for:

• Respiratory tract infections
• Otitis media
• Skin and skin structure infections
• Bone infections
• Genitourinary tract infections

Approved in Canada as Keflex for:

• Respiratory tract infections
• Otitis media
• Skin and skin structure infections
• Bone infections
• Genitourinary tract infections

Approved in Switzerland as Keflex for:

• Respiratory tract infections
• Otitis media
• Skin and skin structure infections
• Bone infections
• Genitourinary tract infections

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Vanderbilt University School of Medicine

Collaborator

Trials

16

Recruited

13,900+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Loma Linda University

Collaborator

Trials

322

Recruited

267,000+

Findings from Research

Cephalexin is a highly effective antibiotic for treating streptococcal and staphylococcal skin infections, achieving cure rates of 90% or higher over 12 years of use.

It is well-absorbed and bioavailable, with a twice-daily dosage that improves patient compliance, and its mild side effects make it suitable for young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of cephalexin in the treatment of skin and soft-tissue infections. Derrick, CW., Reilly, K.[2013]

In a study of over 6 million individuals, new penicillin allergies were reported more frequently after parenteral exposure (0.85%) compared to oral exposure (0.74%), indicating a higher risk of allergic reactions with injectable forms.

Anaphylaxis was rare, with only 22 cases associated with oral penicillin and 3 with parenteral penicillin, suggesting that while allergic reactions can occur, they are infrequent. Additionally, Clostridioides difficile infections were more common after parenteral antibiotic use, highlighting a potential safety concern with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Reactions Associated with Penicillins, Carbapenems, Monobactams, and Clindamycin: A Retrospective Population-based Study. Liang, EH., Chen, LH., Macy, E.[2021]

In a study of 1128 total hip and knee arthroplasties, patients receiving cefazolin had significantly lower rates of surgical site infections (SSIs) compared to those receiving clindamycin or vancomycin (0.9% vs 3.8%).

The use of cefazolin did not result in a higher frequency of interoperative hypersensitivity reactions compared to clindamycin or vancomycin, suggesting it is a safe option for patients labeled as beta-lactam allergic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cefazolin vs Second-line Antibiotics for Surgical Site Infection Prevention After Total Joint Arthroplasty Among Patients With a Beta-lactam Allergy. Norvell, MR., Porter, M., Ricco, MH., et al.[2023]

Cefazolin is associated with fewer adverse events and lower rates of surgical site infections compared to alternative antibiotics used for surgical prophylaxis, highlighting its efficacy and safety.

In a study of perioperative inpatients across 100 U.S. hospitals, patients with a documented β-lactam allergy were significantly less likely to receive cefazolin, while clindamycin was much more frequently prescribed, indicating a potential shift in antibiotic choice despite cefazolin's advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of β-Lactam Allergy Documentation and Prophylactic Antibiotic Use in Surgery: A National Cross-Sectional Study of Hospitalized Patients. Bertram, CM., Postelnick, M., Mancini, CM., et al.[2021]

Acute rhinosinusitis is a leading cause of antibiotic prescriptions globally, raising concerns about antibiotic resistance and the safety of commonly used antibiotics like macrolides and fluoroquinolones.

A surveillance study on the new cephalosporin drug Spectracef (Cefditoren) showed promising efficacy and safety for treating acute bacterial rhinosinusitis, particularly due to its different chemical structure that may reduce the risk of cross-allergy with penicillins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A study of the efficacy and safety of new cephalosporin in the treatment of acute bacterial rhinosinusitis]. Savlevich, EL., Kozlov, VS., Zharkykh, MA.[2018]

References

1. Canada pubmed.ncbi.nlm.nih.gov

In vitro activity of clindamycin and other antimicrobials against gram-positive bacteria and Hemophilus influenzae. [2018]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

A Randomized, Double-blinded, Open Label Study of the Efficacy and Safety of Cefcapene Pivoxil and Amoxicillin·Clavulanate in Acute Presumed Bacterial Rhinosinusitis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The role of cephalexin in the treatment of skin and soft-tissue infections. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Changing antibiotic resistance patterns for Staphylococcus aureus surgical site infections. [2020]

5. Spain pubmed.ncbi.nlm.nih.gov

[Diagnosis and treatment of acute rhinosinusitis: second consensus]. [2008]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Reactions Associated with Penicillins, Carbapenems, Monobactams, and Clindamycin: A Retrospective Population-based Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Cefazolin vs Second-line Antibiotics for Surgical Site Infection Prevention After Total Joint Arthroplasty Among Patients With a Beta-lactam Allergy. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Association of β-Lactam Allergy Documentation and Prophylactic Antibiotic Use in Surgery: A National Cross-Sectional Study of Hospitalized Patients. [2021]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A study of the efficacy and safety of new cephalosporin in the treatment of acute bacterial rhinosinusitis]. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Prophylaxis with cefazolin plus clindamycin in clean-contaminated maxillofacial surgery. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Use of clindamycin as an alternative antibiotic prophylaxis. [2022]