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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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ClinicalTrials.gov Identifier: NCT01076049
Recruitment Status : Terminated (suboptimal recruitment)
First Posted : February 25, 2010
Last Update Posted : June 14, 2013
Sponsor:
Information provided by (Responsible Party):
Irrimax Corporation

Study Description
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Brief Summary:
Does irrigation with IrriSept prevent infected wound progression when compared to usual care?

Condition or disease Intervention/treatment Phase
Non-complicated Skin and Soft Tissue Infections Other: observation of SOP Device: IrriSept Irrigation Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Evaluation of a Novel Solution, IrriSept, Containing a Long-Acting Antimicrobial Agent for Irrigation of Skin and Soft Tissue Infections in the Emergency Setting
Study Start Date : December 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Standard Care
purely observes standard operation of ER doctor
 Other: observation of SOP
standard treatment of infection
Experimental: Irrisept Arm Device: IrriSept Irrigation
irrigation of the wound using IrriSept


Outcome Measures
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Primary Outcome Measures :
  1. State of wound [ Time Frame: 48 hours ]
    physician assessment of wound at 48 hours - either as cured, improved, no change or progression


Secondary Outcome Measures :
  1. Methicillin-resistant Staphylococcus aureus (MRSA) colonisation Rate [ Time Frame: 48 hours ]

    rates of MRSA nares colonisation

    subjective measures of discomfort/pain



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076049


Locations
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United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Irrimax Corporation
Investigators
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Principal Investigator: Erin Stirling University South Florida
More Information
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Responsible Party: Irrimax Corporation
ClinicalTrials.gov Identifier: NCT01076049    
Other Study ID Numbers: 108527
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: June 14, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Soft Tissue Infections
 Emergencies
Disease Attributes
Pathologic Processes