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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSlagelse Hospital

About this trial

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 criteria

Qualifiers

Adults >18 years.

Undergoing emergency or elective laparotomy.

Primary or delayed primary wound closure (DPC).

Wound classification: clean, clean-contaminated, contaminated, or dirty.

Disqualifiers

Laparoscopic surgery

Wounds healing by secondary intention.

Ongoing wound dehiscence treatment with Negative Pressure Wound Therapy (NPWT).

Non-Danish residents

Trial design

Treatments tested in this trial

  • Point-of-Care Ultrasound (POCUS)
  • Microbiological Wound Swab
  • ASEPSIS Wound Assessment
  • Standardized Wound Photography

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

Slagelse Hospital

Lead sponsor

Zealand University Hospital

Collaborator

Copenhagen University Hospital at Herlev

Collaborator