Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)

A Phase II Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus in MRSA Positive Ulcers

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.

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