Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07549880

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

Led by Slagelse Hospital · Updated on 2026-04-24

100

Participants Needed

3

Research Sites

72 weeks

Total Duration

On this page

Sponsors

S

Slagelse Hospital

Lead Sponsor

Z

Zealand University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old
  • Undergoing emergency or elective open abdominal surgery (laparotomy)
  • Wounds closed by primary or delayed primary closure
  • Wound classified as clean, clean-contaminated, contaminated, or dirty
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Laparoscopic surgery
  • Wounds healing by secondary intention (not closed primarily)
  • Currently receiving Negative Pressure Wound Therapy (NPWT) for wound dehiscence
  • Not a resident of Denmark

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Copenhagen University Hospital - Herlev & Gentofte

Herlev, Capital Region, Denmark, 2730

Actively Recruiting

2

Zealand University Hospital - Køge

Køge, Region Sjælland, Denmark, 4600

Actively Recruiting

3

Slagelse Hospital

Slagelse, Region Sjælland, Denmark, 4200

Actively Recruiting

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Research Team

T

Talha Malik, MD

CONTACT

M

Michael Tvilling Madsen, MD, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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