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The Effect Of Wound Irrigation With Irrisept™ Delivery System On Abscess Healing In Patients Presenting To The Emergency Department

This study has been completed.
Sponsor:
Collaborator:
Irrimax Corporation
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01302548
First received: September 29, 2010
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to determine if wound cleansing and irrigation using the IRRISEPT Chlorhexidine Gluconate(CHG)solution, applying a given volume with a pressurized stream, will improve the outcome for infected abscesses in patients that present in the emergency department.


Condition Intervention
Abscess
 Device: IRRISEPT
Procedure: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: THE EFFECT OF WOUND IRRIGATION WITH IRRISEPT™ Delivery System ON ABSCESS HEALING IN PATIENTS PRESENTING TO THE EMERGENCY DEPARTMENT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Compared to "usual care methods" the use of IRRISEPT solution on abscesses will improve healing. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    "usual methods" include saline irrigation and incision & drainage


Secondary Outcome Measures:
  • Assess whether use of IRRISEPT could lead to fewer patients requiring oral antibiotics. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Access effectiveness of IRRISEPT with patients that are MRSA-positive. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: February 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IRRISEPT
Device containing sterile water and chlorhexidine gluconate (CHG)
 Device: IRRISEPT
Device containing sterile water and chlorhexidine gluconate (CHG)
Active Comparator: Usual Care
The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
 Procedure: Usual Care
The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Other Names:
  • Saline irrigation
  • Incision & Drainage

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Immunocompetent individuals 12 years of age or older with an uncomplicated abscess
  • Patient must be able to answer questions and be medically stable as defined by the Emergency Department physician
  • Patient must voluntarily participate in the study

Exclusion Criteria:Patients with any of the following are excluded:

  • Currently receiving antibiotics or received antibiotics within last 72 hours
  • Evidence of systemic infection (fever, aches, chills, nausea)
  • Requires admission to the hospital for infection or for any other reason(s)
  • Abscess caused by a human or animal bite
  • Prior history of hypersensitivity or allergy to Chlorhexidine Gluconate (CHG)
  • Immunodeficiency (Examples: HIV Positive, Crohns Disease, Systemic Lupus Erythematosus, Addison's disease, psoriasis, splenectomy, leukemia, cancer on chemotherapy)
  • Currently on any immune-modifying medication (Examples: prednisone, antivirals)
  • History of chronic skin infection (3 or more in the past year)
  • Chronic medical problem, for example end-stage heart, liver, kidney, or lung disease, diabetes mellitus, peripheral vascular disease, history of organ transplant
  • Mental illness including but not limited to substance abuse, dementia, schizophrenia or mentally handicapped or challenged
  • Incarcerated
  • Patient is pregnant or thinks she may be pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302548

Locations
United States, Florida
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Irrimax Corporation
Investigators
Principal Investigator: Richard F Petrik, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01302548     History of Changes
Other Study ID Numbers: 20101227
Study First Received: September 29, 2010
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Abscess
Wound Irrigation
Wound Debridement
 Wound Healing
Incision and drainage
Chlorhexidine

Additional relevant MeSH terms:
Abscess
Emergencies
Suppuration
Infection
Inflammation
Pathologic Processes
Disease Attributes
Chlorhexidine
 Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013