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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to use antibiotics during and after nose surgery (rhinoplasty) to prevent infections. Researchers aim to determine if a single dose of antibiotics during the operation is as effective as adding a few days of oral antibiotics afterward. The trial involves two antibiotics: cephalexin and clindamycin. Suitable candidates for this trial are those planning their first rhinoplasty and without a history of immune issues or previous nose surgeries. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to important medical advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both cephalexin and clindamycin are commonly used antibiotics with proven safety records. Cephalexin often prevents infections during surgery. One study found that antibiotics like cephalexin, when used before surgery, can significantly reduce infections, indicating it is generally well-tolerated for this purpose.

Clindamycin also prevents infections during surgery but may cause side effects like nausea, vomiting, and diarrhea. More serious effects, such as a severe colon infection called pseudomembranous colitis, are less common but possible.

Both antibiotics have FDA approval for other uses, suggesting they are generally safe. However, awareness of potential side effects, especially with clindamycin, remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using antibiotics like cephalexin and clindamycin in rhinoplasty because these treatments aim to prevent infection with a streamlined approach. Unlike standard protocols that may involve longer courses of antibiotics, this approach involves a single intra-operative intravenous dose followed by a short, three-day oral course. This method potentially reduces the risk of antibiotic resistance and side effects due to prolonged use. By targeting infections with precision and efficiency, these antibiotics could improve recovery times and outcomes for rhinoplasty patients.

What evidence suggests that this trial's treatments could be effective for nasal surgery?

Research has shown that cephalexin can lower the risk of infections at surgical sites. One study found it reduced these infections by 15.9%. Another study found no extra benefit from using cephalexin for more than one dose before surgery in some cases. In this trial, participants in Treatment Arm A will receive a single intra-operative dose of either cephalexin or clindamycin. Participants in Treatment Arm B will receive the same single intra-operative dose followed by postoperative oral doses for three days. Clindamycin works well against certain bacteria like S. aureus when combined with other antibiotics. However, using clindamycin alone may not lower infection risk in nose surgeries. Both antibiotics can be effective, but their benefits may depend on the type of surgery and the patient's condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Sam P Most, MD

Principal Investigator

Stanford Facial Plastic and Reconstructive Surgery

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5914724/

Effect of a single prophylactic preoperative oral antibiotic ... Antibiotic prophylaxis resulted in an absolute SSI reduction of 15.9% (95% CI 5.2% to 26.6%) and a relative SSI reduction of 100% in men.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04580472?term=AREA%5BBasicSearch%5D(CEFALEXIN%20HYDROCHLORIDE)&rank=5

Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of ... The purpose of the study is to assess the effectiveness of a single dose of preoperative antibiotic in reducing surgical site infections in certain ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6368070/

Effect of a Single Preoperative Dose of Oral Antibiotic to ... A single oral 2-g dose of cephalexin given before complex below-knee dermatological closure did not reduce SSI.

4. researchgate.net researchgate.net/publication/324623899_Effect_of_a_single_prophylactic_preoperative_oral_antibiotic_dose_on_surgical_site_infection_following_complex_dermatological_procedures_on_the_nose_and_ear_A_prospective_randomised_controlled_double-

Effect of a single prophylactic preoperative oral antibiotic ... The objective of this study was to determine the effectiveness of a single oral preoperative 2 g dose of cephalexin in preventing SSI following flap and graft ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352587824000172

Efficacy of 24 hours versus 5 days of prophylactic ... The primary outcome was the need for postoperative antibiotics within 6 weeks of surgery. Results. 204 patients met the inclusion criteria: 104 in the 5-day ...

6. binasss.sa.cr binasss.sa.cr/nov24/28.pdf

Safety in Rhinoplasty A highly satisfactory rhinoplasty outcome is certainly visible in the early postoperative period, within 6 weeks of surgery, both from the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6439733/

Evaluation of Antibiotic Prophylaxis in Rhinoplasty Postoperative antibiotic therapy did not significantly alter the rate of infections after rhinoplasty procedures.