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Evaluation of IrriSept for Irrigation of Skin and Soft Tissue Infections in the Emergency Room Setting (USF)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Irrimax Corporation
ClinicalTrials.gov Identifier:
NCT01076049
First received: February 23, 2010
Last updated: February 24, 2010
Last verified: February 2010
History of Changes
  Purpose

Does irrigation with IrriSept prevent infected wound progression when compared to usual care?


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by Irrimax Corporation:

Primary Outcome Measures:
  • State of wound [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    physician assessment of wound at 48 hours - either as cured, improved, no change or progression


Secondary Outcome Measures:
  • Methicillin-resistant Staphylococcus aureus (MRSA) colonisation Rate [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

    rates of MRSA nares colonisation

    subjective measures of discomfort/pain



Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076049

Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Irrimax Corporation
Investigators
Principal Investigator: Erin Stirling University South Florida
  More Information

No publications provided

Responsible Party: Sam Zaidspiner / CEO, Irrimax Corporation
ClinicalTrials.gov Identifier: NCT01076049     History of Changes
Other Study ID Numbers: 108527
Study First Received: February 23, 2010
Last Updated: February 24, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Emergencies
Soft Tissue Infections
Disease Attributes
Pathologic Processes
 Infection
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013