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

Study Overview
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Brief Summary
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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.

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

Conditions
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Abscess

Intervention / Treatment
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* Device: IRRISEPT
* Procedure: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRRISEPT<br>Device containing sterile water and chlorhexidine gluconate (CHG) | Device: IRRISEPT<br>* Device containing sterile water and chlorhexidine gluconate (CHG)<br>|
| Active Comparator: Usual Care<br>The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion. | Procedure: Usual Care<br>* The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.<br>* Other names: Incision & Drainage;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abscess, Wound Irrigation, Wound Debridement, Wound Healing, Incision and drainage, Chlorhexidine