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

Condition(s) studied

Investigational drug(s) / intervention(s)

Point-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.

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

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

Standardized Wound Photography: Photographic documentation of the surgical incision at each postoperative assessment to support blinded evaluation.

Study 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

Primary outcome measure(s)

• Incidence of surgical site infection (SSI) within 30 days stratified by presence of POCUS-detected subcutaneous fluid — 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.

Trial sites (3)

More Slagelse Hospital trials in Denmark