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

Abscess Clinical Trial

Official title:

THE EFFECT OF WOUND IRRIGATION WITH IRRISEPT™ Delivery System ON ABSCESS HEALING IN PATIENTS PRESENTING TO THE EMERGENCY DEPARTMENT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01302548
• Other study ID #: 20101227
• Status: Terminated
• Phase: N/A
• First received: September 29, 2010
• Last updated: February 28, 2014
• Start date: February 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess

Intervention

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.

Locations

Country	Name	City	State
United States	Shands Hospital at the University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Irrimax Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Patients Prescribed Oral Antibiotics	Number of patients prescribed oral antibiotics	48 hours	No
Secondary	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	No