Bedside ultrasound to detect early post‑laparotomy wound fluid and predict infection
Official title: Post-Laparotomy Fluid Monitoring With Point of Care Ultrasonography : Predicting Surgical Site Infection & Optimizing Patient Convalescence (SPOTLIGHT Study).
Run by Slagelse Hospital · NCT07549880 · Data updated 2026-11-12
This project will try bedside ultrasound on adults after open abdominal surgery to see if early fluid under the skin predicts a surgical site infection.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Slagelse Hospital Academic / other |
| Locations | 3 sites (Herlev, Capital Region and 2 other locations) |
| Status | Recruiting |
| Started | April 10, 2026 |
| Main results expected | May 31, 2027 |
| Study ends | August 30, 2027 |
| Registry record updated | April 24, 2026 |
| Trial ID | NCT07549880 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 undergoing emergency or elective open laparotomy with primary or delayed primary wound closure who can give informed consent and are treated at participating Danish hospitals are ideal candidates.
✕Probably not a fit
Patients who had laparoscopic procedures, wounds healing by secondary intention, those on ongoing negative pressure wound therapy, or non‑Danish residents are not eligible and would not benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll adults who have had emergency or planned open abdominal surgery and perform a single wound swab and three bedside ultrasound scans of the surgical wound on postoperative days 1–3, 4–6, and 7–9. Wounds will be inspected for redness, swelling, tenderness, or discharge before each scan, and standardized wound photography and ASEPSIS scoring will be recorded. Participants will be followed at 7 and 30 days after surgery (and up to 90 days if an implant is present) to record surgical site infections. The study aims to link early subcutaneous fluid collections seen on point-of-care ultrasound with later development of SSI.
Why it matters
Potential benefit: If successful, earlier detection of fluid collections could allow faster treatment and reduce the rate and severity of surgical site infections.
How similar studies have gone: Point‑of‑care ultrasound is established for identifying superficial fluid collections in other settings, but using serial bedside ultrasound specifically to predict post‑laparotomy SSI is relatively novel and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults \>18 years. * Undergoing emergency or elective laparotomy. * Primary or delayed primary wound closure (DPC). * Wound classification: clean, clean-contaminated, contaminated, or dirty. * Informed consent obtained. Exclusion Criteria: * Laparoscopic surgery * Wounds healing by secondary intention. * Ongoing wound dehiscence treatment with Negative Pressure Wound Therapy (NPWT). * Non-Danish residents
Where it's running
-
Copenhagen University Hospital - Herlev & Gentofte
Herlev, Capital Region, Denmark Recruiting -
Zealand University Hospital - Køge
Køge, Region Sjælland, Denmark Recruiting -
Slagelse Hospital
Slagelse, Region Sjælland, Denmark Recruiting
Study contacts
- Study coordinator: Talha Malik, MD
- Email: exittm@regionsjaelland.dk
- Phone: + 45 20 58 44 06
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.