Testing a Medical Device to predict surgical site infectio
Not Applicable
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/02/031351
- Lead Sponsor
- Crely Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Patients undergoing open abdominal surgeries between the ages of 18 to 80 years
2. ASA I to II
Exclusion Criteria
1. Patients who require preoperative oxygen supplementation
2. Patients who need continuous postoperative oxygenation and ventilatory requirements
3. Patients whose primary wound closure could not be performed
4. Patients with severe COPD
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ability of the developed sensor to predict surgical site infection as early as possible would be tested in 30 patients who undergo open abdominal surgeriesTimepoint: Total duration is 4 months from start of study. Patients will be monitored with the investigational device till POD5
- Secondary Outcome Measures
Name Time Method The ability of the developed sensor would be compared with the gold standard device InspectraTimepoint: Total duration is 4 months from start of study. Patients will be monitored with the investigational device till POD5