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

This study has been terminated.
(suboptimal recruitment)
Information provided by (Responsible Party):
Irrimax Corporation Identifier:
First received: February 23, 2010
Last updated: June 12, 2013
Last verified: June 2013
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 (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 ]
    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 ]

    rates of MRSA nares colonisation

    subjective measures of discomfort/pain

Enrollment: 114
Study Start Date: December 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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


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

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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Please refer to this study by its identifier: NCT01076049

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

Responsible Party: Irrimax Corporation Identifier: NCT01076049     History of Changes
Other Study ID Numbers: 108527
Study First Received: February 23, 2010
Last Updated: June 12, 2013

Additional relevant MeSH terms:
Communicable Diseases
Soft Tissue Infections
Disease Attributes
Pathologic Processes processed this record on September 21, 2017