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
- 35
- 试验地点
- 2
- 主要终点
- Abscess Wound Healing Determined By Pain Score
研究概览
简要总结
The purpose of this study was to evaluate the safety and effectiveness of Irrisept compared to standard of care treatment of skin and soft tissue infections in the form of abscesses.
详细描述
After being informed about the trial and potential risks, subjects completed an informed consent form prior to participation. After eligibility criteria was verified, an initial wound assessment examination was performed. Subjects were then randomized to the Irrisept or Standard of Care treatment group. At intervals of 48 hours (up to 96 hours) later, abscesses were assessed until healing occurred. If the subject required antibiotics, this was recorded, as well as results from the wound and Methicillin-resistant Staphylococcus Aureus (MRSA) cultures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Uncomplicated abscess is defined as ≤8 cm of induration (defined as firmness to touch) at the greatest diameter.
- •≤4 cm of surrounding erythema (surrounding redness).
- •Defined area of central fluctuance may or may not be present.
- •Patient must be able to answer questions.
- •Patient must be medically stable as defined by the emergency department physician.
- •Patient must participate voluntarily in the study.
排除标准
- •Currently receiving antibiotics or received antibiotics within the 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, Crohn's 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.
结局指标
主要结局
Abscess Wound Healing Determined By Pain Score
时间窗: Abscess wound healing, assessed by pain, was reviewed at baseline and the 48-hour visit.
Pain assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Pain was assessed using a Visual Analogue Scale (VAS). The scale was measured in centimeters (cm) which ranged between 0 cm ("no pain" at the far left) to 9.5 cm ("most severe pain" at the far right). Subjects marked their pain rating on the scale with an "X". The distance from the beginning of the scale (far left) to the "X" was measured in cm. The mean VAS score was assessed at baseline and at the 48-hour follow-up visit. The overall mean improvement was compared between the 2 arms using two-tailed t-tests.
Abscess Wound Healing Determined By Wound Improvement Score
时间窗: Abscess wound healing, assessed by wound improvement, was reviewed at the 48-hour visit.
Wound improvement assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Wound improvement was assessed via a clinician's discretion, according to a 5-point Likert scale: 1 = clinically resolved, no signs of active infection; 2 = markedly improved, resolving infection and healing; 3 = improved with some remaining signs of active infection; 4 = unchanged, stable without signs of worsening clinical infection and; 5 = worsening conditions. The results are shown using a chi-squared test, as an average Likert score compared between the 2 arms.
Abscess Wound Healing Determined By Exudation Score
时间窗: Abscess wound healing, assessed by exudation, was reviewed at baseline and the 48-hour visit.
Exudation assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Exudation was assessed via a clinician's discretion, according to a 5-point Likert scale: 1 = none; 2 = scant; 3 = minimal; 4 = moderate and; 5 = copious. The results are shown using a chi-squared test to compare the means at baseline and 48-hours. A two-tailed t-test was conducted for the mean improvement.
Number of Subjects That Used Oral Antibiotics
时间窗: 24, 48, 72 & 96-hour visit intervals
Oral antibiotic use was used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline).
次要结局
- Oral Antibiotic Use Required, Determined By Induration (Abscess Area Size)(48-hours after baseline)
- Oral Antibiotic Use Required Due To Fluctuance(The need for oral antibiotics, assessed by fluctuance, was reviewed at baseline and the 48-hour visit.)
- Oral Antibiotic Use Required, Determined By Erythema Area Size(The need for oral antibiotics, assessed by erythema, was reviewed at baseline and the 48-hour visit.)
- Oral Antibiotic Use Required Due To Warmth(The need for oral antibiotics, assessed by warmth, was reviewed at baseline and the 48-hour visit.)