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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 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

September 29, 2010
February 28, 2014
February 2011
August 2012   (final data collection date for primary outcome measure)
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

  • Patient requiring oral antibiotics [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Wound improvement as assessed on a 5-point Likert scale [ Time Frame: every 48 hours until wound is healed ] [ Designated as safety issue: No ]
  • Exudate as assessed using a 5-point Likert scale [ Time Frame: every 48 hours until wound is healed ] [ Designated as safety issue: No ]
  • Patient comfort (pain) as assessed by patient using a 10cm Visual Analog Scale [ Time Frame: every 48 hours until wound is healed ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01302548 on ClinicalTrials.gov Archive Site
  • 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

  • Erythema measured by the longest and shortest axes on the most lateral edges [ Time Frame: every 48 hours until wound is healed ] [ Designated as safety issue: No ]
  • Abscess size (length and width in centimeters) [ Time Frame: every 48 hours until wound is healed ] [ Designated as safety issue: No ]
  • Warmth-measured as an increase in temperature of skin surrounding the wound (yes/no) measured as an increase in temperature surrounding the wound) [ Time Frame: every 48 hours until wound is healed ] [ Designated as safety issue: No ]
  • Fluctuance-presence of fluid under the skin determined by palpation (yes/no) [ Time Frame: every 48 hours until the wound is healed ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Effect Of Wound Irrigation With Irrisept™ Delivery System On Abscess Healing In Patients Presenting To The Emergency Department
THE EFFECT OF WOUND IRRIGATION WITH IRRISEPT™ Delivery System ON ABSCESS HEALING IN PATIENTS PRESENTING TO THE EMERGENCY DEPARTMENT

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Abscess
  • Device: IRRISEPT
    Device containing sterile water and chlorhexidine gluconate (CHG)
  • 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
  • Experimental: IRRISEPT
    Device containing sterile water and chlorhexidine gluconate (CHG)
    Intervention: Device: IRRISEPT
  • Active Comparator: Usual Care
    The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
    Intervention: Procedure: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01302548
20101227
Yes
University of Florida
University of Florida
Irrimax Corporation
Principal Investigator: Richard F Petrik, MD University of Florida
University of Florida
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP