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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01076049 |
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Date of registration:
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23/02/2010 |
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Primary sponsor: |
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Public title:
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Evaluation of IrriSept for Irrigation of Skin and Soft Tissue Infections in the Emergency Room Setting
USF |
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Scientific title:
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Evaluation of a Novel Solution, IrriSept, Containing a Long-Acting Antimicrobial Agent for Irrigation of Skin and Soft Tissue Infections in the Emergency Setting |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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100 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01076049 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
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Countries of recruitment
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United States
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Contacts
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Name:
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Erin Stirling |
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Address:
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Telephone:
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Email:
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Affiliation:
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University South Florida |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18 to 80.
- SSTls, including abscesses, cutaneous surgical site infections, infected wounds, etc.
- Patient able to provide an informed consent.
- Patient volunteers to participate.
Exclusion Criteria:
- Wound was caused by human or animal bite.
- Wound is a blunt crush injury or has tendon, bone or joint involvement.
- Diabetic foot infection.
- Admission to hospital for any reason, including IV antibiotics.
- Clinical signs of systemic infection on initial patient encounter.
- Prior history of allergy or hypersensitivity to CHG.
- Neutropenia (known ANC<500/mm3), HIV (known CD4<50), or other severely
immunocompromised state (e.g. receiving chemotherapy).
- Pt is diagnosed with systemic lupus erythematosus or other immunological disease.
- Patient withdraws from participation.
- Patient unable or unwilling to give informed consent.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-complicated Skin and Soft Tissue Infections
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Intervention(s)
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Device: IrriSept Irrigation
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Other: observation of SOP
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Primary Outcome(s)
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State of wound
[Time Frame: 48 hours]
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Secondary Outcome(s)
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Methicillin-resistant Staphylococcus aureus (MRSA) colonisation Rate
[Time Frame: 48 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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