search
Back to results

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

Primary Purpose

Abscess

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IRRISEPT
Usual Care
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess focused on measuring Abscess, Wound Irrigation, Wound Debridement, Wound Healing, Incision and drainage, Chlorhexidine

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shands Hospital at the University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IRRISEPT

Usual Care

Arm Description

Device containing sterile water and chlorhexidine gluconate (CHG)

The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.

Outcomes

Primary Outcome Measures

Abscess Healing Based on Abscess Measurement Scale
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
Number of patients prescribed oral antibiotics
Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.
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

Full Information

First Posted
September 29, 2010
Last Updated
February 28, 2014
Sponsor
University of Florida
Collaborators
Irrimax Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01302548
Brief Title
The Effect Of Wound Irrigation With Irrisept™ Delivery System On Abscess Healing In Patients Presenting To The Emergency Department
Official Title
THE EFFECT OF WOUND IRRIGATION WITH IRRISEPT™ Delivery System ON ABSCESS HEALING IN PATIENTS PRESENTING TO THE EMERGENCY DEPARTMENT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Study did not accrue the required number of study subjects.
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Irrimax Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess
Keywords
Abscess, Wound Irrigation, Wound Debridement, Wound Healing, Incision and drainage, Chlorhexidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IRRISEPT
Arm Type
Experimental
Arm Description
Device containing sterile water and chlorhexidine gluconate (CHG)
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Intervention Type
Device
Intervention Name(s)
IRRISEPT
Intervention Description
Device containing sterile water and chlorhexidine gluconate (CHG)
Intervention Type
Procedure
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Saline irrigation, Incision & Drainage
Intervention Description
The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Primary Outcome Measure Information:
Title
Abscess Healing Based on Abscess Measurement Scale
Description
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
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Number of Patients Prescribed Oral Antibiotics
Description
Number of patients prescribed oral antibiotics
Time Frame
48 hours
Title
Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.
Description
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
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard F Petrik, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs