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Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

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ClinicalTrials.gov Identifier: NCT06044428
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Study Description
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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.

Condition or disease Intervention/treatment
Body Temperature Postoperative Infection Pneumonia Device: Steadytemp®

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement
Actual Study Start Date : August 14, 2023
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : May 2024
Groups and Cohorts
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Intervention Details:
  • Device: Steadytemp®
    Steadytemp® is a clinical thermometer intended to continuously measure axillary temperature and to display relative changes in axillary temperature to the user. The system consists of a sensor patch and a smartphone application, the body temperature measured by the sensor is transmitted via Near-Field-Communication (NFC) and subsequently displayed in the App.

Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. wound infection or pneumonia [ Time Frame: min. 5 days and max. 21 days ]
    Number of patients diagnosed with wound infection or pneumonia


Secondary Outcome Measures :
  1. Inflammation parameter in the blood: PCT (Procalcitonin) [ Time Frame: min. 5 days and max. 21 days ]
    PCT (Procalcitonin) level

  2. Inflammation parameter in the blood: CRP (c-reactive protein) [ Time Frame: min. 5 days and max. 21 days ]
    CRP (c-reactive protein) level

  3. Inflammation parameter in the blood: Leukocytes [ Time Frame: min. 5 days and max. 21 days ]
    Leukocytes count

  4. Use of medication [ Time Frame: min. 5 days and max. 21 days ]
    Use of medication like antibiotics, antiphlogistics, antipyretics


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Participants will be inpatients at the Medical University of Graz, where the need to have a visceral surgery.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044428


Contacts
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Contact: Dr. Philipp Stiegler, Assoc. Prof. 004331638581181 philipp.stiegler@medunigraz.at
Contact: Dickel Franziska, Dr. 004331638583232 franziska.dickel@medunigraz.at

Locations
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Austria
Medical University of Graz Recruiting
Graz, Austria, 8010
Contact: Dr. Robert Sucher, Prof. PD    004338514094    dagmar.schloffer@medunigraz.at   
Contact: Dr. Philipp Stiegler, Assoc. Prof.    004331638581181    philipp.stiegler@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Dr. Philipp Stiegler, Assoc. Prof. Medical University Graz, Department of Surgery, Division of general, visceral and transplant surgery
More Information
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT06044428    
Other Study ID Numbers: Ek-Nr.: 35-251 ex 22/23
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes