Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered 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
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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