Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07549880

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Diagnostic Evaluation

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

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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