Decolonization to Reduce After-Surgery Events of Surgical Site Infection
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,700
- 试验地点
- 8
- 主要终点
- Time to First Post-Discharge Surgical Site Infection
研究概览
简要总结
The DECREASE SSI Trial (Decolonization to Reduce After-Surgery Events of Surgical Site Infection) is a two-arm multi-center individual placebo-controlled randomized (2,700 participants randomized 1:1) clinical trial to reduce post-discharge surgical site infection following open colon or small bowel surgery by comparing chlorhexidine bathing plus nasal mupirocin in the 30 days following discharge to soap without antiseptic properties (placebo) and placebo nasal ointment. This trial seeks to enhance the care of the 675,000 patients annually who undergo colon and small bowel surgery by finding simple and efficacious interventions to reduce SSI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Recent open (not solely laparoscopic) surgery involving an abdominal incision within the past 14 days. For cesarean section, recruitment restricted to BMI ≥
- •Able to communicate regularly by phone
- •Able to bathe, shower or have this task performed by a caregiver
排除标准
- •Transfer to an acute care hospital
- •Discharged to receive end-of-life hospice measures
- •Discharged more than 14 days after surgery
- •Allergic to mupirocin and/or chlorhexidine
- •Active infection at enrollment*
- •*Refers to
- •Infections requiring systemic antibacterial agents, so viral illness (e.g., COVID, flu) is not an exclusion.
- •Topical antibacterial agents do not count toward exclusion (e.g., topical products for acne)
- •Prophylactic antibacterial agents do not count toward exclusion
- •Surgical incision not closed at discharge
研究组 & 干预措施
Decolonization
Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).
干预措施: 2% Mupirocin (Drug)
Routine Care
Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.
干预措施: Soap Without Antiseptic Properties (Placebo) (Drug)
Routine Care
Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.
干预措施: Placebo Nasal Ointment (Drug)
Decolonization
Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).
干预措施: 4% Chlorhexidine Gluconate (Drug)
结局指标
主要结局
Time to First Post-Discharge Surgical Site Infection
时间窗: Within 30 Days of Hospital Discharge
次要结局
未报告次要终点
研究者
Susan Huang
Professor, Division of Infectious Diseases and Medical Director, Epidemiology and Infection Prevention
University of California, Irvine