MedPath

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

Not Applicable
Completed
Conditions
Health Condition 1: O- Medical and Surgical
Registration Number
CTRI/2022/01/039722
Lead Sponsor
Crely Healthcare Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
205
Inclusion Criteria

Patients undergoing coronary bypass surgery, between the age group 18-80 years at the time of admission

Exclusion Criteria

Subjects who are known cases of HIV

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The ability of the developed sensor to collect the <br/ ><br>digital biomarkers of surgical site infection will be assessedTimepoint: Total duration of the study is 9 months from the start of study.
Secondary Outcome Measures
NameTimeMethod
The ability of the sensor to detect an SSI will be <br/ ><br>compared with the actual diagnosis of infection <br/ ><br>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 postoperative day 14.
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