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
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: 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
Suppuration
Infection
Inflammation
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on September 18, 2014