Study Stopped
limited recruitment
Reduction of Bacteria in MRSA Positive Ulcers
A Clinical Trial on the Reduction of Bacteria (Including MRSA) in MRSA Positive Ulcers and Lesions
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJanuary 19, 2012
January 1, 2012
4 months
October 10, 2008
January 18, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in bacteria
Post Treatment Day 3
Secondary Outcomes (1)
Incidence of adverse events
3 days
Study Arms (1)
Nitric Oxide
EXPERIMENTALgaseous nitric oxide delivered topically for 30 minutes
Interventions
1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 10, 2008
First Posted
October 13, 2008
Study Start
January 1, 2009
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
January 19, 2012
Record last verified: 2012-01