RecruitingNot ApplicableNCT07549880

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

Post-Laparotomy Fluid Monitoring With Point of Care Ultrasonography : Predicting Surgical Site Infection & Optimizing Patient Convalescence (SPOTLIGHT Study).


Sponsor

Slagelse Hospital

Enrollment

100 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • Laparoscopic surgery
  • Wounds healing by secondary intention.
  • Ongoing wound dehiscence treatment with Negative Pressure Wound Therapy (NPWT).
  • Non-Danish residents

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Interventions

DIAGNOSTIC_TESTPoint-of-Care Ultrasound (POCUS)

Three standardized postoperative ultrasound examinations performed on post-operative day 1-3, 4-6, and 7-9 to measure subcutaneous fluid collections and assess the risk of surgical site infection.

DIAGNOSTIC_TESTMicrobiological Wound Swab

Single postoperative swab of the closed incision and surrounding skin obtained between POD 1-3 for microbiological assessment.

DIAGNOSTIC_TESTASEPSIS Wound Assessment

Structured wound scoring performed at each postoperative assessment to evaluate clinical signs of surgical site infection.

DIAGNOSTIC_TESTStandardized Wound Photography

Photographic documentation of the surgical incision at each postoperative assessment to support blinded evaluation.


Locations(3)

Copenhagen University Hospital - Herlev & Gentofte

Herlev, Capital Region, Denmark

Zealand University Hospital - Køge

Køge, Region Sjælland, Denmark

Slagelse Hospital

Slagelse, Region Sjælland, Denmark

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NCT07549880


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