Methicillin-resistant Staphylococcus Aureus Infection, Skin Ulcers
Conditions
Brief summary
The purpose of the study is to determine if topically applied nitric oxide gas is effective in reducing the quantity of bacteria (including MRSA)in a wound.
Interventions
DRUGNitric Oxide
Gaseous nitric oxide (1%), delivered for 30 minutes per day for 3 consecutive days
Sponsors
Nitric BioTherapeutics, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have given written informed consent * Must be ≥ 18 years of age and not of child bearing potential * Must have an ulcer in which the presence of MRSA has been identified, but which is not clinically infected * Must have an ulcer size not to extend beyond the inner borders of the dressing
Exclusion criteria
* Is a female of child bearing years or who could become pregnant * Is \< 18 years of age * Has an clinically infected skin ulcer * Has a ulcer that is being treated with a topical antimicrobial agent or has been treated with a topical antimicrobial agent during 3 days prior to enrolment * Has been using systemic antibiotics during 7 days prior to enrolment into this study * Has an ulcer which is identified as malignant in origin (e.g. Marjolin's ulcer) * Has an ulcer size beyond the inner borders of the dressing * Is septic or has other signs of an invasive infection * Has used any investigational drug within 30 days preceding study participation. * Suffers from a condition, which, in the opinion of the Investigator, would compromise his or her safety. * Suffers from a condition which, in the opinion of the Investigator, would compromise the quality of the data. * Has a known allergy to any of the products that are part of this protocol * Suffers from a condition which, in the opinion of the Investigator, would seriously interfere negatively with the normal parameters of immune response to an infection. * Is using any of the prohibited concomitant medications or treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in bioburden (specifically MRSA)as assessed via quantitative cultures. | 10 Days |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the condition of the ulcer as judged by comparative photography and independent clinical assessment | 10 Days |
| Incidence of adverse events | 10 Days |
Countries
United Kingdom
Outcome results
None listed