Teste the Safety of (Polymyxin B Sulfate 500,000 IU, Bacitracin Zinc 40,000 IU, Neomycin Sulfate 0.35g Neomycin Base) Intranasally
Conditions
Keywords
Neosporin, Intranasal, safety
Brief summary
Neosporin is an over-the-counter, FDA-approved triple-antibiotic ointment. It is widely used to treat and prevent skin infections following minor burns and injuries. Although the Neosporin® prospect indicates its use is strictly topical, it is often used intranasally by ear, nose, and throat specialists, plastic surgeons, and intensivists to prevent and treat various conditions. Nonetheless, no literature has documented the safety of intranasal Neosporin®. We designed a prospective study to assess the safety of this intervention in healthy participants and to investigate microbial changes before and after the intervention. Healthy participants will apply Neosporin® intranasally for 15 days and record daily adverse events and their severity. Nasal cultures will be drawn before and after the intervention and compared.
Interventions
DRUGIntranasal application of Polymyxin B Sulfate 500,000 IU, Bacitracin zinc 40,000 IU, Neomycin Sulfate 0.35g neomycin base
We want to test the safety of the intranasal application of Neosporin® (Polymyxin B Sulfate 500,000 IU, Bacitracin zinc 40,000 IU, Neomycin Sulfate 0.35g neomycin base) since it has not been tested. Sing and symptom diaries and nasal swabs for culture will be collected
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 65 years * Signed informed consent * Healthy volunteers
Exclusion criteria
* Chronic or recurrent nasal conditions * Current use of other intranasal medications * History of severe allergic reactions to antibiotics * History of allergy to the components of Neosporin® * Participation in another research protocol * Being a staff member or an immediate family member of a staff member * Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events of intranasal Neosporin® in healthy participants. | 16 days |
Countries
Mexico
Contacts
STUDY_DIRECTORAdrian Camacho Ortiz, MD, PhD
Hospital Universitario Dr. José Eleuterio González
Outcome results
None listed