Body TemperatureNCT06044428
Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement
An observational study of Body Temperature and Postoperative Infection, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Temperature, Postoperative Infection, Pneumonia
- What is being tested?
- Steadytemp®
- Type of treatment
- Medical device
- How many people
- 103 participants
- Where
- 1 siteAustria
- Study dates
- 14 Aug 2023to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Participants will be inpatients at the Medical University of Graz, where the need to have a visceral surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Body Temperature, Postoperative Infection, Pneumonia
- Being tested
- Steadytemp®
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature curve (body temperature in °C)
temperature curve of the Steadytemp® Patch and single routine measurements (infrared)
Measured: min. 5 days and max. 21 days
wound infection or pneumonia
Number of patients diagnosed with wound infection or pneumonia
Measured: min. 5 days and max. 21 days
Secondary outcomes (4)
Inflammation parameter in the blood: PCT (Procalcitonin)
PCT (Procalcitonin) level
Measured: min. 5 days and max. 21 days
Inflammation parameter in the blood: CRP (c-reactive protein)
CRP (c-reactive protein) level
Measured: min. 5 days and max. 21 days
Inflammation parameter in the blood: Leukocytes
Leukocytes count
Measured: min. 5 days and max. 21 days
Use of medication
Use of medication like antibiotics, antiphlogistics, antipyretics
Measured: min. 5 days and max. 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start14 Aug 2023
- Primary completion30 May 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body TemperatureStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Philipp Stiegler, Assoc. Prof., Principal investigator, Medical University Graz, Department of Surgery, Division of general, visceral and transplant surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044428
- Sponsor's protocol ID
- Ek-Nr.: 35-251 ex 22/23
- Status last verified
- Jul 2024
- First submitted
- 28 Aug 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement
- ClinicalTrials.gov ID
- NCT06044428
- Acronym / sponsor ID
- Ek-Nr.: 35-251 ex 22/23
- Conditions
- Body Temperature, Postoperative Infection, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be inpatients at the Medical University of Graz, where the need to have a visceral surgery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
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
4 secondary outcomes
Inflammation parameter in the blood: PCT (Procalcitonin)
Time frame: 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
Inflammation parameter in the blood: Leukocytes
Time frame: min. 5 days and max. 21 days
Use of medication
Time frame: min. 5 days and max. 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Philipp Stiegler, Assoc. Prof. principal investigator
Medical University Graz, Department of Surgery, Division of general, visceral and transplant surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Temperature and Postoperative Infection, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature curve (body temperature in °C) (time frame: min. 5 days and max. 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.