A Group-Randomized, Standard-of-Care-Controlled, Crossover Trial Evaluating Nasal Antimicrobial Photodisinfection for the Prevention of Surgical Site Infections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,787
- 试验地点
- 27
- 主要终点
- Number of Participants with a Surgical Site Infection (SSI) within 30 days post surgery
研究概览
简要总结
This is a Phase 3 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major elective, urgent, or emergent surgeries in a hospital setting. The main outcomes are to:
- compare the efficacy, and
- estimate the safety of applying nasal (aPDT) before surgery in reducing the incidence of SSIs within the initial 30 days after surgery compared to standard of care (SOC).
Participants in the intervention group will receive aPDT prior to surgery on the day of surgery.
Participants in the control group will receive standard of care surgical site prevention measures prior to surgery.
详细描述
This study employs a group-randomized crossover design, comparing outcomes from the treatment group with that of a standard-of-care control group from the same hospitals. Each hospital ('site') engaged in the study will be randomly assigned to treatment plus standard-of-care or standard-of-care control on a 1:1 basis and will enroll patients into those respective groups during the first period of the study. After an approximate 6-week inactive interval period, each site will crossover to enroll the alternate group, up to a number of patients that matches the site's first period (or up to 10% more).
Eligible patients who successfully complete all screening assessments and meet inclusion and exclusion criteria will be enrolled. Patients in the treatment group will undergo aPDT treatment after admission to the preoperative area. All patients will be followed up for a 30-day post-surgery period. A patient-reported outcome (PRO) assessment to gauge the tolerability of the intervention after administration will also be performed in the treatment group.
Standard-of-care infection control practices will be applied according to infection prevention policies and procedures in place at each hospital. These practices are to remain unchanged for both groups throughout the study.
Microbiological samples will also be collected from any SSI and evaluated to establish the causative organism and its antibiotic susceptibility.
The incidence of SSIs during the 30-day postoperative period will be tracked to ensure comprehensive follow-up evaluations. In-person unscheduled visits will be conducted for medical assessment of suspected SSIs and collection of wound cultures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- •Surgical patients, willing to sign the informed consent form and participate in the study.
- •≥ 18 years of age
- •Presenting to an acute care hospital for major elective, urgent, or emergency surgery, defined as an open procedure involving a significant skin incision, including but not limited to the following types:
- •Orthopedic, including spine and 'clean' trauma
- •Neurosurgery
- •Breast surgeries
- •Are able to follow instructions, comply with protocol requirements, and participate in all required study visits.
排除标准
- •Pregnancy (current) or currently lactating. If patient is unsure of pregnancy status, a negative urine or serum pregnancy test (sensitive to 25 IU hCG) should be obtained within 14 days prior to surgery.
- •Surgical indication of infection.
- •History of surgery within 90 days prior to enrollment.
- •Anticipated surgery other than the index surgical procedure prior to patient's completion of the study.
- •Use of other nasal decolonization procedures on the day of surgery prior to the index procedure (mupirocin, povidone iodine, alcohol, etc.).
- •Patient has any medical, social or psychiatric condition(s) or current substance abuse condition that, in the opinion of the investigator, would preclude the patient's ability to provide informed consent, or to comply with the study requirements.
- •Enrollment in concomitant investigational research study in the past 30 days.
- •Exclusion Criteria Specific to Treatment Group Patients Only:
- •Inability to tolerate insertion of the nasal light illuminator due to nasal obstructions or nares size, shape, or anatomical variants.
- •Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.
研究组 & 干预措施
Standard of Care Surgical Preventions - Control
Standard of Care surgical site prevention measures
Nasal antimicrobial photodisinfection therapy (aPDT)
Nasal antimicrobial photodisinfection therapy
干预措施: nasal antimicrobial photodisinfection therapy (Combination Product)
结局指标
主要结局
Number of Participants with a Surgical Site Infection (SSI) within 30 days post surgery
时间窗: Through 30 days post surgery
Percentage of Participants with Treatment-Related Adverse Events within 30 days after surgery.
时间窗: Through 30 days post surgery
次要结局
- Mean hospital length of stay after surgery(From day of surgery (from 1 day up to 30 days))
- Number of hospital readmissions within 30 days of surgery(From day of surgery through 30 days post surgery)
- Number of Participants with Staph aureus nasal colonization following aPDT (substudy)(Immediately following aPDT treatment)