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

University of Florida

Status: Terminated

Conditions: Abscess

Treatments: Device: IRRISEPT; Procedure: Usual Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01302548

20101227

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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33 participants in 2 patient groups

IRRISEPT

Experimental group

Description:

Device containing sterile water and chlorhexidine gluconate (CHG)

Treatment:

Device: IRRISEPT

Usual Care

Active Comparator group

Description:

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

Treatment:

Procedure: Usual Care