Antibiotic Irrigations for Intra-Abdominal Drains
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Duration of systemic antibiotics
研究概览
简要总结
Intra-abdominal abscesses are pus-filled pouches in the abdominal cavity. Current standard of care includes drain placement in the abscess cavity to reach source control as well as administration of systemic antibiotics. It is common practice to flush the drain on a daily basis to ensure patency. This study aims to analyze the clinical impact of a higher local concentration of antibiotics (rather than normal saline) provided through drain irrigation with an antimicrobial agent (Gentamicin and/or Clindamycin) compare to normal saline.
详细描述
People with an abdominal abscess who undergo drain placement will have those drains irrigated twice/day with either normal saline (placebo group) or with the above antibiotic solution for a total of 7 days or less if the drain were to be removed earlier. Outcomes of interest are duration of systemic antibiotics, and WBC and temperature curve.
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
- Single (Participant)
盲法说明
Written consent will be obtained from all participants. Then, each participant will be randomized into two arms. Nurse will administer the drain flush either with normal saline or antibiotic irrigation.
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
- 是
入选标准
- •Intra-abdominal abscess drained with catheter/drain
- •Treatment with systemic antibiotics
- •Able to consent
排除标准
- •Abscess(es) not amendable for an image guided drain placement.
研究组 & 干预措施
Normal Saline Irrigation
The drain will be irrigated twice/day with normal saline
干预措施: Placebo (Other)
Antibiotic Irrigation
The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum
干预措施: Gentamicin Sulfate Inj 20mg/2ml vial for injection (Drug)
Antibiotic Irrigation
The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum
干预措施: Clindamycin phosphate 6 mg/1ml for injection (Drug)
结局指标
主要结局
Duration of systemic antibiotics
时间窗: From initiation of systemic treatment until 1 month follow up
Total duration of systemic antibiotics will be recorded from the start of the treatment until discontinuation by primary care team. This will be measured as days from diagnosis to when the antibiotic treatment gets interrupted. Duration of systemic antibiotics will be our primary outcome measurement. Duration of systemic antibiotics will be monitored as an indication of the effectiveness of the proposed intervention.
Duration of Systemic Antibiotics:
时间窗: From initiation of systemic treatment until 1 month follow up
Total duration of systemic antibiotics will be recorded from the start of the treatment until discontinuation by primary care team. This will be measured as days from diagnosis to when the antibiotic treatment gets interrupted. Duration of systemic antibiotics will be our primary outcome measurement. Duration of systemic antibiotics will be monitored as an indication of the effectiveness of the proposed intervention.
次要结局
- Changes in Drain Output(From the drain placement up to 1 month follow up)
- Change in temperature(From initiation of systemic treatment until 1 month follow up)
- White Blood Count(From initiation of systemic treatment until 1 month follow up)
- Duration of drain(From the drain placement until 1 month follow up)
- Changes in size of the Abscess(From patient initial hospitalization up to 1 month follow up)
- Maximum Temperature From Initiation of Systemic Treatment Until 1 Month Follow up(From initiation of systemic treatment until 1 month follow up)