Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

July 29, 2024 updated by: Medical University of Graz
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Participants will be inpatients at the Medical University of Graz, where the need to have a visceral surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
min. 5 days and max. 21 days
wound infection or pneumonia
Time Frame: min. 5 days and max. 21 days
Number of patients diagnosed with wound infection or pneumonia
min. 5 days and max. 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation parameter in the blood: PCT (Procalcitonin)
Time Frame: min. 5 days and max. 21 days
PCT (Procalcitonin) level
min. 5 days and max. 21 days
Inflammation parameter in the blood: CRP (c-reactive protein)
Time Frame: min. 5 days and max. 21 days
CRP (c-reactive protein) level
min. 5 days and max. 21 days
Inflammation parameter in the blood: Leukocytes
Time Frame: min. 5 days and max. 21 days
Leukocytes count
min. 5 days and max. 21 days
Use of medication
Time Frame: min. 5 days and max. 21 days
Use of medication like antibiotics, antiphlogistics, antipyretics
min. 5 days and max. 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Dr. Philipp Stiegler, Assoc. Prof., Medical University Graz, Department of Surgery, Division of general, visceral and transplant surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ek-Nr.: 35-251 ex 22/23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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