Health TrialsbyHealthPanel

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

ConditionsSurgical Site Infection (SSI)Emergency LaparotomiesPoint of Care Ultrasound (POCUS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSlagelse Hospital

About this trial

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. Does ultrasound identify subcutaneous fluid collections early after surgery? 2. Do these fluid collections help predict which participants will develop a surgical site infection?

Intervention:

Participants will:

1. Have a superficial wound swab taken once at the start of the study (for research only). 2. Receive three ultrasound scans of their surgical wound during days 1-3, 4-6, and 7-9 after surgery. 3. Have their wound checked for redness, swelling, tenderness, or discharge before each scan. 4. 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.

Ultrasound is non-invasive and safe. According to the protocol, "no serious adverse effects are expected," though some participants may feel brief discomfort from pressure on a tender wound.

This study will help researchers understand whether routine bedside ultrasound can support earlier detection of wound infections and improve postoperative care in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults >18 years.

Undergoing emergency or elective laparotomy.

Primary or delayed primary wound closure (DPC).

Wound classification: clean, clean-contaminated, contaminated, or dirty.

Disqualifiers

Laparoscopic surgery

Wounds healing by secondary intention.

Ongoing wound dehiscence treatment with Negative Pressure Wound Therapy (NPWT).

Non-Danish residents

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • Microbiological Wound Swab

    Diagnostic test

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

  • ASEPSIS Wound Assessment

    Diagnostic test

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

  • Standardized Wound Photography

    Diagnostic test

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Laparotomy Patient CohortExperimental treatment 4 interventions

Trial outcomes

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.

Time frame
30 days post-operative

Secondary outcomes

1

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

Sensitivity, specificity, and predictive values of POCUS, ASEPSIS, and their combined use will be calculated for identifying SSI. Diagnostic performance will be compared using AUROC analysis.

Time frame
Baseline to 30 days post-operative
2

Accuracy of electronic wound imaging for detecting surgical site infection

Standardized wound photographs will be evaluated to determine whether electronic imaging supports or improves detection of SSI when used alongside ASEPSIS scoring.

Time frame
Baseline to 30 days post-operative
3

Microbiological profile of laparotomy wounds associated with surgical site infection

Microbiological swabs obtained between POD 1-3 will be analyzed to identify organisms associated with increased SSI risk.

Time frame
Post-operative day 1-3
4

Rate of 30-day readmissions related to surgical site infection

All-cause and SSI-related readmissions will be recorded, including cases where POCUS identified subclinical fluid collections not detected clinically.

Time frame
Baseline to 30 days post-operative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Slagelse Hospital

Lead sponsor

Zealand University Hospital

Collaborator

Copenhagen University Hospital at Herlev

Collaborator

Source ClinicalTrials.gov
Apply now