The Spotlight Study: Early Identification of Post-Surgical Infections Using Bedside Ultrasound.

NCT07549880 | Recruiting DMC

• 4 other identifiers: VEK- SJ-1126A2653R53-A263026-2-16562
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.Does ultrasound identify subcutaneous fluid collections early after surgery?
2. 2.Do these fluid collections help predict which participants will develop a surgical site infection?
3. 3.Have a superficial wound swab taken once at the start of the study (for research only).
4. 4.Receive three ultrasound scans of their surgical wound during days 1-3, 4-6, and 7-9 after surgery.
5. 5.Have their wound checked for redness, swelling, tenderness, or discharge before each scan.
6. 6.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.

Conditions

Emergency Laparotomies; Surgical Site Infection (SSI); Point of Care Ultrasound (POCUS)

Keywords

point of care ultrasound (POCUS); surgical site infection (SSI); Emergency laparotomies

Outcome Measures

Primary Outcomes (1)

• Incidence of surgical site infection (SSI) within 30 days stratified by presence of POCUS-detected subcutaneous fluid

  SSI occurrence will be compared between participants with and without postoperative subcutaneous fluid collections detected on point-of-care ultrasound. SSI will be defined according to CDC criteria. Fluid presence and volume will be recorded during scheduled POCUS examinations.

  30 days post-operative

Secondary Outcomes (4)

• Diagnostic accuracy of combined POCUS and ASEPSIS scoring for detecting surgical site infection

  Baseline to 30 days post-operative

• Accuracy of electronic wound imaging for detecting surgical site infection

  Baseline to 30 days post-operative

• Microbiological profile of laparotomy wounds associated with surgical site infection

  Post-operative day 1-3

• Rate of 30-day readmissions related to surgical site infection

  Baseline to 30 days post-operative

Study Arms (1)

Laparotomy Patient Cohort

EXPERIMENTAL

Participants undergoing emergency or elective laparotomy will be followed prospectively with standardized wound assessment, microbiological sampling, and serial point-of-care ultrasound examinations to evaluate subcutaneous fluid accumulation and development of surgical site infection.

Diagnostic Test: Point-of-Care Ultrasound (POCUS); Diagnostic Test: Microbiological Wound Swab; Diagnostic Test: ASEPSIS Wound Assessment; Diagnostic Test: Standardized Wound Photography

Interventions

Point-of-Care Ultrasound (POCUS) DIAGNOSTIC_TEST

Three standardized postoperative ultrasound examinations performed on post-operative day 1-3, 4-6, and 7-9 to measure subcutaneous fluid collections and assess the risk of surgical site infection.

Also known as: Bedside Ultrasonography

Laparotomy Patient Cohort

Microbiological Wound Swab DIAGNOSTIC_TEST

Single postoperative swab of the closed incision and surrounding skin obtained between POD 1-3 for microbiological assessment.

Laparotomy Patient Cohort

ASEPSIS Wound Assessment DIAGNOSTIC_TEST

Structured wound scoring performed at each postoperative assessment to evaluate clinical signs of surgical site infection.

Laparotomy Patient Cohort

Standardized Wound Photography DIAGNOSTIC_TEST

Photographic documentation of the surgical incision at each postoperative assessment to support blinded evaluation.

Laparotomy Patient Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Laparoscopic surgery
• Wounds healing by secondary intention.
• Ongoing wound dehiscence treatment with Negative Pressure Wound Therapy (NPWT).
• Non-Danish residents

Sponsors & Collaborators

• Slagelse Hospital: lead
• Zealand University Hospital: collaborator
• Copenhagen University Hospital at Herlev: collaborator

Study Sites (3)

Copenhagen University Hospital - Herlev & Gentofte

Herlev, Capital Region, 2730, Denmark

RECRUITING

Zealand University Hospital - Køge

Køge, Region Sjælland, 4600, Denmark

RECRUITING

Slagelse Hospital

Slagelse, Region Sjælland, 4200, Denmark

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Pállson Nolsøe, MD, Ph.D

  Zealand University Hospital

  STUDY CHAIR

• Jakob Burcharth, MD, Ph.D

  Copenhagen University Hospital at Herlev

  STUDY DIRECTOR

Central Study Contacts

Talha Malik, MD

CONTACT

+ 45 20 58 44 06; exittm@regionsjaelland.dk

Michael Tvilling Madsen, MD, Ph.D

CONTACT

mitm@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 24, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)