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Набира участници Не е приложимо NCT07549880

The Spotlight Study: Early Identification of Post-Surgical Infections Using Bedside Ultrasound.

Не е приложима фаза (напр. обсервационно)
Заболявания: Surgical Site Infection (SSI) Emergency Laparotomies Point of Care Ultrasound (POCUS)

Спонсор: Slagelse Hospital

Налично на: БГ
Обобщение
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: 1. Does ultrasound identify subcutaneous fluid collections early after surgery? 2. Do these fluid collections help predict which participants will develop a surgical site infection? Intervention: Participants will: 1. Have a superficial wound swab taken once at the start of the study (for research only). 2. Receive three ultrasound scans of their surgical wound during days 1-3, 4-6, and 7-9 after surgery. 3. Have their wound checked for redness, swelling, tenderness, or discharge before each scan. 4. 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.
Описание
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. Point of care ultrasonography (POCUS) has gained increasing attention as a non-invasive and real-time imaging modality that can enhance the early detection of subcutaneous fluid accumulation. Several studies have demonstrated the utility of POCUS in identifying fluid pockets, allowing for timely drainage and targeted management, potentially reducing the risk of SSI. However, dependent on operator's level of expertise conflicting findings have also been reported in literature regarding the accuracy of POCUS in evaluating fluid collection resulting SSIs. Some evidence suggests that POCUS combined with physical examination may improve diagnostic precision. Despite growing interest in POCUS for postoperative wound evaluation, standardized protocols for the routine use of ultrasound in postoperative wound assessment are lacking, and the association between ultrasound-detected fluid and SSI development remains inadequately studied. Furthermore, to the best of our knowledge there is no prior study evaluating that POCUS adds diagnostic value when used in combination with ASEPSIS in identifying SSI. Purpose of the study: The aim of this prospective study is to evaluate the diagnostic utility of bedside ultrasound in early detection of subcutaneous fluid accumulation following laparotomy and its correlation with development of SSIs. Additionally, the study will assess whether POCUS added with the ASEPSI
Кой може да участва
Inclusion Criteria: * 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. Exclusion Criteria: * Laparoscopic surgery * Wounds healing by secondary intention. * Ongoing wound dehiscence treatment with Negative Pressure Wound Therapy (NPWT). * Non-Danish residents
Интервенции
Point-of-Care Ultrasound (POCUS)
DIAGNOSTIC_TEST
Microbiological Wound Swab
DIAGNOSTIC_TEST
ASEPSIS Wound Assessment
DIAGNOSTIC_TEST
Standardized Wound Photography
DIAGNOSTIC_TEST
Места на провеждане 3
Дания (3)
Copenhagen University Hospital - Herlev & Gentofte
Herlev , Capital Region
Zealand University Hospital - Køge
Køge , Region Sjælland
Christian P Nolsøe, MD, Ph.D
Slagelse Hospital
Slagelse , Region Sjælland
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
10.04.2026
Крайна дата
30.08.2027
Регистрационен номер
NCT07549880
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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