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.

Study Overview

• Status: Terminated
• Conditions: Abscess
• Intervention / Treatment: Device: IRRISEPT; Procedure: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands Hospital at the University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Prescribed Oral Antibiotics	Number of patients prescribed oral antibiotics	48 hours
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	48 hours

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Irrimax Corporation
• Investigators: Principal Investigator: Richard F Petrik, MD, University of Florida

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: September 29, 2010
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): April 7, 2014
• Last Update Submitted That Met QC Criteria: February 28, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Abscess; Wound Healing; Incision and drainage; Chlorhexidine; Wound Irrigation; Wound Debridement
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Disease Attributes; Suppuration; Emergencies; Abscess
• Other Study ID Numbers: 20101227