Reduction of Bacteria in MRSA Positive Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Leg Ulcer Pressure Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nitric Oxide

gaseous nitric oxide delivered topically for 30 minutes

Group Type EXPERIMENTAL

Nitric Oxide

Intervention Type DRUG

1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days

Interventions

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Nitric Oxide

1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No