The Effect Of Wound Irrigation With Irrisept™ Delivery System On Abscess Healing In Patients Presenting To The Emergency Department
- Conditions
- Abscess
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
- 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
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
- 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
Shands Hospital at the University of Florida🇺🇸Gainesville, Florida, United States