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

This study has been terminated.
(Study did not accrue the required number of study subjects.)
Sponsor:
Collaborator:
Irrimax Corporation
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01302548
First received: September 29, 2010
Last updated: February 28, 2014
Last verified: February 2014
  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:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Abscess Healing Based on Abscess Measurement Scale [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

    The abscess healing process will use two methods: 1) "usual method" includes saline irrigation and/or incision & drainage, and 2) the use of IRRISEPT solution. The Abscess Measurement Scale was measured using a centimeter ruler.

    Scale 8cm - 10cm = Severe 6cm - 8cm = Moderate/severe 4cm - 6cm = Moderate 2cm - 4cm = Mild/moderate 0cm - 2cm = Mild



Secondary Outcome Measures:
  • Number of Patients Prescribed Oral Antibiotics [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Number of patients prescribed oral antibiotics

  • Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

    The Abscess Measurement Scale was measured using a centimeter ruler.

    Scale 8cm - 10cm = Severe 6cm - 8cm = Moderate/severe 4cm - 6cm = Moderate 2cm - 4cm = Mild/moderate 0cm - 2cm = Mild



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
Results First Received: September 9, 2013
Last Updated: February 28, 2014
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 April 16, 2014