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

Not Applicable

Terminated

• Conditions: Abscess
• Interventions: Procedure: Usual Care; Device: IRRISEPT

• Registration Number: NCT01302548
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-29
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-24
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2013-09-09
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-28
• Last Update Submitted: 2014-02-28
• Results First Posted: 2014-04-07
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
IRRISEPT	IRRISEPT	Device containing sterile water and chlorhexidine gluconate (CHG)

Primary Outcome Measures

Name	Time	Method
Abscess Healing Based on Abscess Measurement Scale	48 hours	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

Name	Time	Method
Number of Patients Prescribed Oral Antibiotics	48 hours	Number of patients prescribed oral antibiotics
Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.	48 hours	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

Trial Locations

Locations (1)

Shands Hospital at the University of Florida; 🇺🇸 Gainesville, Florida, United States