Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

Sponsor
Medical University of Graz (Other)
Overall Status
Recruiting
CT.gov ID
NCT06044428
Collaborator
(none)
100
1
6.6
15.2

Study Details

Study Description

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 Phase
  • Device: Steadytemp®

Study Design

Study Type:
Observational
Anticipated 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 :
Aug 14, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Temperature curve (body temperature in °C) [min. 5 days and max. 21 days]

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

  2. wound infection or pneumonia [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) [min. 5 days and max. 21 days]

    PCT (Procalcitonin) level

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

    CRP (c-reactive protein) level

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

    Leukocytes count

  4. Use of medication [min. 5 days and max. 21 days]

    Use of medication like antibiotics, antiphlogistics, antipyretics

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Medical University of Graz Graz Austria 8010

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT06044428
Other Study ID Numbers:
  • Ek-Nr.: 35-251 ex 22/23
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023