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Testing Medical Device (Sensor) to detect and predict surgical site infections

An academic study of the investigation of Digital Biomarkers for Early Detection of Surgical Site Infections.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/01/039350
Enrollment
90
Registered
2022-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

None listed

Sponsors

Crely Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing orthopedic surgical procedures in the knee, hip, or the spine, between the age group 18-80 years at the time of admission

Exclusion criteria

Exclusion criteria: Revision procedures in the knees, hip, or spine

Design outcomes

Primary

MeasureTime frame
The ability of the developed sensor to collect the digital biomarkers of surgical site infection will be assessedTimepoint: Total duration of the study is 9 months from the start of study.—

Secondary

MeasureTime frame
The ability of the sensor to detect an SSI will be compared with the actual diagnosis of infection by the attending clinicianTimepoint: Total duration of the study is 9 months from the start of study.Patients will be monitored with the investigational device until discharge.—

Countries

India

Contacts

Public ContactDr A Navaladi Shankar

Apollo Hospitals, Chennai

principalinvestigator.apollo@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026