THE EFFECT OF WOUND IRRIGATION WITH IRRISEPT™ Delivery System ON ABSCESS HEALING IN PATIENTS PRESENTING TO THE EMERGENCY DEPARTMENT
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Abscess Healing Based on Abscess Measurement Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IRRISEPT
Device containing sterile water and chlorhexidine gluconate (CHG)
干预措施: IRRISEPT (Device)
Usual Care
The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
干预措施: Usual Care (Procedure)
结局指标
主要结局
Abscess Healing Based on Abscess Measurement Scale
时间窗: 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
次要结局
- Number of Patients Prescribed Oral Antibiotics(48 hours)
- Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.(48 hours)