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Clinical Trials/NCT06044428
NCT06044428
Completed
Not Applicable

Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

Medical University of Graz1 site in 1 country103 target enrollmentAugust 14, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Body Temperature
Sponsor
Medical University of Graz
Enrollment
103
Locations
1
Primary Endpoint
Temperature curve (body temperature in °C)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this observational study is to review whether postoperative infections can be detected earlier by a continuous measurement of body temperature of patients compared to single daily measurements. Within 25 weeks 100 patients, which underwent visceral surgery less than 48h ago, will be included. A patch (Steadytemp ®) will be attached to participants, continuously measuring the body temperature. In addition infection parameters and medication of the participants will be documented.

Registry
clinicaltrials.gov
Start Date
August 14, 2023
End Date
July 15, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical University of Graz
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • participant is willing and able to give informed consent for participation in the study
  • age 18 years and above
  • visceral surgery procedure within the last two days
  • inpatient stay on the ICIÜ (Interdisciplinary surgical intensive care unit) or normal ward

Exclusion Criteria

  • allergy to the ingredients of skin patches
  • major psychiatric diseases including history of drug or alcohol abuse
  • chronic inflammatory disease in the medical history
  • predicted inpatient stay is less than 5 days
  • operational wound is too close to the patch adhesive site
  • the skin at the intended adhesive site of the patch is not intact
  • BMI \> 33

Outcomes

Primary Outcomes

Temperature curve (body temperature in °C)

Time Frame: min. 5 days and max. 21 days

temperature curve of the Steadytemp® Patch and single routine measurements (infrared)

wound infection or pneumonia

Time Frame: min. 5 days and max. 21 days

Number of patients diagnosed with wound infection or pneumonia

Secondary Outcomes

  • Inflammation parameter in the blood: PCT (Procalcitonin)(min. 5 days and max. 21 days)
  • Use of medication(min. 5 days and max. 21 days)
  • Inflammation parameter in the blood: CRP (c-reactive protein)(min. 5 days and max. 21 days)
  • Inflammation parameter in the blood: Leukocytes(min. 5 days and max. 21 days)

Study Sites (1)

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