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

Study Overview
=================
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.

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

Conditions
-----------------
Skin Ulcers, Methicillin-resistant Staphylococcus Aureus Infection

Intervention / Treatment
-----------------
* Drug: Nitric Oxide


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nitric Oxide|Gaseous nitric oxide (1%), delivered for 30 minutes per day for 3 consecutive days|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bioburden (specifically MRSA)as assessed via quantitative cultures. |  | 10 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |