limited recruitment

The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers

Inclusion Criteria:

• Must have given written informed consent
• Must be 19 years of age or over
• Must have an ulcer or lesion in which the presence of MRSA has been positively identified but which is not clinically infected.
• Must have an Ulcer / Lesion size not to extend beyond the inner borders of the wound cover

Exclusion Criteria:

• Is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence)
• Is < 19 years of age
• Has a clinically infected ulcer
• Has an Ulcer / Lesion that is currently treated 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 / Lesion which is identified as malignant in origin (e.g., Marjolin's ulcer)
• Has an Ulcer / Lesion size beyond the inner borders of the wound cover
• Is septic or has other signs of an invasive infection
• Has used any other investigational product 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