Actively Recruiting
Post-Laparotomy Fluid Monitoring Using Point-of-Care Ultrasound to Predict Surgical Site Infection and Improve Recovery
Led by Slagelse Hospital · Updated on 2026-04-24
100
Participants Needed
3
Research Sites
13 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
Researchers are evaluating whether point-of-care ultrasound (POCUS) can detect early fluid build-up under the skin after open abdominal surgery (laparotomy) and if these findings can predict surgical site infections (SSI). The study focuses on adults who recently underwent emergency or planned open abdominal surgery. It also examines whether combining POCUS with the ASEPSIS wound scoring system improves the accuracy of SSI detection compared to either method alone. This observational study aims to enhance early diagnosis and improve care after surgery. Participants will receive a single wound swab between days 1 and 3 after surgery for microbiological analysis. They will undergo three standardized ultrasound scans of their surgical wound on postoperative days 1-3, 4-6, and 7-9. Each scan will be accompanied by wound assessments using the ASEPSIS scoring system and standardized wound photography. The ultrasound is non-invasive, using a sterile technique, and is performed with the patient lying down. The study emphasizes consistency and training to ensure reliable ultrasound evaluations across different investigators. During the study, wounds will be checked for signs of infection such as redness, swelling, tenderness, or discharge before each scan. Participants will be followed up at 7 and 30 days after surgery, and up to 90 days if they have implanted mesh, to monitor infection development and hospital readmissions. Data will be collected in a secure database, including demographic, clinical, and microbiological information. The main outcome measured is the incidence of SSI within 30 days after surgery, stratified by ultrasound findings of subcutaneous fluid. The study plans to enroll about 100 patients to ensure enough data for analysis.
CONDITIONS
Brief Title
The Spotlight Study: Early Identification of Post-Surgical Infections Using Bedside Ultrasound.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years
- Undergoing emergency or elective laparotomy
- Primary or delayed primary wound closure
- Wound classification: clean, clean-contaminated, contaminated, or dirty
- Informed consent obtained
You will not qualify if you...
- Laparoscopic surgery
- Wounds healing by secondary intention
- Current treatment with Negative Pressure Wound Therapy (NPWT) for wound dehiscence
- Not a resident of Denmark
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Postoperative day 1 to 3
Participants undergo standardized postoperative wound assessment including microbiological swab, photography, and ASEPSIS wound scoring to evaluate signs of surgical site infection.
1 visit (in-person) for microbiological swab, photography, and ASEPSIS scoring
Duration - Postoperative day 1 to 9
Participants receive three standardized point-of-care ultrasound (POCUS) examinations to detect subcutaneous fluid accumulation as an early indicator of surgical site infection, accompanied by photography and ASEPSIS scoring.
3 visits (in-person) occurring on days 1-3, 4-6, and 7-9 post-surgery
Duration - Postoperative day 10 to 30
Participants are followed up via telephone and electronic health record review to monitor wound outcomes and any surgical site infection related readmissions.
Telephone follow-up and health registry review at 7 and 30 days post-surgery
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
M
Michael Tvilling Madsen, MD, Ph.D
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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