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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)
Sponsor:
Information provided by (Responsible Party):
Irrimax Corporation
ClinicalTrials.gov Identifier:
NCT01076049
First received: February 23, 2010
Last updated: June 12, 2013
Last verified: June 2013
  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



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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Irrimax Corporation
ClinicalTrials.gov Identifier: NCT01076049     History of Changes
Other Study ID Numbers: 108527
Study First Received: February 23, 2010
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Communicable Diseases
Infection
Soft Tissue Infections

ClinicalTrials.gov processed this record on November 25, 2014