Bedside ultrasound to detect early post‑laparotomy wound fluid and predict infection
Post-Laparotomy Fluid Monitoring With Point of Care Ultrasonography : Predicting Surgical Site Infection & Optimizing Patient Convalescence (SPOTLIGHT Study).
NA · Slagelse Hospital · NCT07549880
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Slagelse Hospital (other) |
| Locations | 3 sites (Herlev, Capital Region and 2 other locations) |
| Trial ID | NCT07549880 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Herlev, Capital Region and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Surgical Site Infection, Emergency Laparotomies, Point of Care Ultrasound, point of care ultrasound, surgical site infection, Emergency laparotomies