NCT01076049终止不适用
Evaluation of a Novel Solution, IrriSept, a New Delivery System, Containing a Long-acting Antimicrobial Agent for Irrigation of Skin and Soft Tissue Infections, in the Form of an Abscess in the Emergency Department: a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Wound State at 48-Hour Follow-up Visit
研究概览
简要总结
The purpose of this study was to determine whether Irrisept can effectively prevent the progression of skin and soft tissue infections (SSTIs) as compared to treatment by the current Standard of Care.
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. Forty-eight hours later, wound progression and signs of infection were assessed.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80
- •Skin and soft tissue infections (SSTIs), in the form of an abscess, which will require incision and drainage.
- •Patient able to provide an informed consent.
- •Patient volunteers to participate.
排除标准
- •Wound was caused by human or animal bite.
- •Wound is a blunt crush injury or has tendon, bone, or joint involvement.
- •Diabetic foot infection.
- •Anticipated incision size less than 5mm.
- •Abscess extends to the muscle layer.
- •Admission to hospital for any reason, including IV antibiotics.
- •Clinical signs of systemic infection on initial patient encounter.
- •Prior history of allergy or hypersensitivity to CHG.
- •Neutropenic (known ANC<500/mm3), HIV (known CD4<50), or other severely immunocompromised state (e.g., receiving chemotherapy).
- •Patient is diagnosed with systemic lupus erythematosus or other immunological disease.
- •Currently in police custody.
- •Patient withdraws from participation.
- •Patient unable or unwilling to give informed consent.
结局指标
主要结局
Wound State at 48-Hour Follow-up Visit
时间窗: 48 hours
The primary endpoint was overall wound progression and signs of infection 48 hours post-treatment. This was measured via a blinded investigator's discretion and recorded as 'improved', 'no change', 'progression of signs or symptoms of infection', or 'immediate treatment required' if an infection had progressed to a certain extent.
次要结局
- Clinical Performance of Irrisept to the Current SoC(48 hours)
研究者
研究点 (2)
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