Post-Laparotomy Fluid Monitoring With Point of Care Ultrasonography : Predicting Surgical Site Infection & Optimizing Patient Convalescence (SPOTLIGHT Study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Incidence of surgical site infection (SSI) within 30 days stratified by presence of POCUS-detected subcutaneous fluid
研究概览
简要总结
Introduction:
The goal of this observational study is to learn whether point-of-care ultrasound (POCUS) can help detect early fluid build-up under the skin after open abdominal surgery (laparotomy) and whether these findings can predict surgical site infection. The study includes adults who recently had emergency or planned open abdominal surgery.
Hypothesis:
The main questions it aims to answer are:
- Does ultrasound identify subcutaneous fluid collections early after surgery?
- Do these fluid collections help predict which participants will develop a surgical site infection?
Intervention:
Participants will:
- Have a superficial wound swab taken once at the start of the study (for research only).
- Receive three ultrasound scans of their surgical wound during days 1-3, 4-6, and 7-9 after surgery.
- Have their wound checked for redness, swelling, tenderness, or discharge before each scan.
- Be followed for 7 and 30 days after surgery (and up to 90 days if they have implanted mesh) to see whether an infection develops.
Ultrasound is non-invasive and safe. According to the protocol, "no serious adverse effects are expected," though some participants may feel brief discomfort from pressure on a tender wound.
This study will help researchers understand whether routine bedside ultrasound can support earlier detection of wound infections and improve postoperative care in the future.
详细描述
Background:
Surgical site infections (SSIs) remain a major concern in postoperative care, particularly following major emergency abdominal surgery (MEAS), where infection rates range from 8% to 23%, depending on a range of patient related (endogenous) and surgical related (exogenous) risk factors. SSIs are associated with significant clinical and economic burdens, including a 2- to 11-fold increase in mortality (absolute 7.4%), prolonged hospital stays, additional surgical procedures and readmissions. Furthermore, associated healthcare costs estimated $ 3.3 billion in United States and € 1.47-19.1 billion in Europe.
Subcutaneous fluid accumulation, such as seromas and hematomas, may serve as a nidus for bacterial growth and impair wound healing, thereby predisposing patients to SSIs. However, early detection of such fluid collections is challenging using routine postoperative clinical assessment.
Traditional clinical examination and wound inspection often in accordance to CDC criteria for SSIs, makes it challenging to accurately diagnose and report true SSIs, potentially missing deep or small fluid collections. As a result, SSIs may go undetected until after discharge, with reported rate ranging from 12% to 84%.
In comparison to CDC- guidelines for identifying SSI, which is subjective to interpretation due to the arbiter factor of 'diagnosis by attending physician'. In contrast, the ASEPSIS wound scoring system offers a more objective assessment and has shown more reliability in identifying SSIs, though it still depends on observable clinical signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Adults >18 years.
- •Undergoing emergency or elective laparotomy.
- •Primary or delayed primary wound closure (DPC).
- •Wound classification: clean, clean-contaminated, contaminated, or dirty.
- •Informed consent obtained.
排除标准
- •Laparoscopic surgery
- •Wounds healing by secondary intention.
- •Ongoing wound dehiscence treatment with Negative Pressure Wound Therapy (NPWT).
- •Non-Danish residents
研究组 & 干预措施
Laparotomy Patient Cohort
Participants undergoing emergency or elective laparotomy will be followed prospectively with standardized wound assessment, microbiological sampling, and serial point-of-care ultrasound examinations to evaluate subcutaneous fluid accumulation and development of surgical site infection.
干预措施: Point-of-Care Ultrasound (POCUS) (Diagnostic Test)
Laparotomy Patient Cohort
Participants undergoing emergency or elective laparotomy will be followed prospectively with standardized wound assessment, microbiological sampling, and serial point-of-care ultrasound examinations to evaluate subcutaneous fluid accumulation and development of surgical site infection.
干预措施: Microbiological Wound Swab (Diagnostic Test)
Laparotomy Patient Cohort
Participants undergoing emergency or elective laparotomy will be followed prospectively with standardized wound assessment, microbiological sampling, and serial point-of-care ultrasound examinations to evaluate subcutaneous fluid accumulation and development of surgical site infection.
干预措施: ASEPSIS Wound Assessment (Diagnostic Test)
Laparotomy Patient Cohort
Participants undergoing emergency or elective laparotomy will be followed prospectively with standardized wound assessment, microbiological sampling, and serial point-of-care ultrasound examinations to evaluate subcutaneous fluid accumulation and development of surgical site infection.
干预措施: Standardized Wound Photography (Diagnostic Test)
结局指标
主要结局
Incidence of surgical site infection (SSI) within 30 days stratified by presence of POCUS-detected subcutaneous fluid
时间窗: 30 days post-operative
SSI occurrence will be compared between participants with and without postoperative subcutaneous fluid collections detected on point-of-care ultrasound. SSI will be defined according to CDC criteria. Fluid presence and volume will be recorded during scheduled POCUS examinations.
次要结局
- Diagnostic accuracy of combined POCUS and ASEPSIS scoring for detecting surgical site infection(Baseline to 30 days post-operative)
- Accuracy of electronic wound imaging for detecting surgical site infection(Baseline to 30 days post-operative)
- Microbiological profile of laparotomy wounds associated with surgical site infection(Post-operative day 1-3)
- Rate of 30-day readmissions related to surgical site infection(Baseline to 30 days post-operative)