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Completed

NCT Number: NCT06044428

Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

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.

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Key information

Conditions

Body Temperature Infections Lung Diseases Pneumonia Postoperative Infection Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, 8010, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Steadytemp®

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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