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

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.

Conditions

• Surgical Site Infection (SSI)
• Emergency Laparotomies
• Point of Care Ultrasound (POCUS)

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Microbiological Wound Swab

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

DIAGNOSTIC_TEST

ASEPSIS Wound Assessment

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

DIAGNOSTIC_TEST

Standardized Wound Photography

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

Sponsors & Collaborators

• Zealand University Hospital

  collaborator OTHER

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• Slagelse Hospital

  lead OTHER

Principal Investigators

• Christian Pállson Nolsøe, MD, Ph.D · Zealand University Hospital

• Jakob Burcharth, MD, Ph.D · Copenhagen University Hospital at Herlev

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-10

Primary Completion

2027-05-31

Completion

2027-08-30

Countries

• Denmark

Study Locations