Testing a Medical Device to predict surgical site infection
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2021/02/031351
- Lead Sponsor
- Crely Healthcare Ltd
- Brief Summary
**Brief Summary of the Study:**
**Objective:** Theobjective of this study is to collect digital biomarker (tissue oxygensaturation) measurements from patients using a near-infrared spectrophotometrydevice to explore early warning for surgical site infection.
**Methodology:** Crely has developed a sensor for continuous monitoring of tissuesaturation of Oxygen (StO2) that has higher potency in early prediction ofsurgical site infection. About 30 patients undergoing open abdominal surgeriesbetween the ages of 18 to 80 years would be enrolled in the study. The studyinvolves use of a gold standard device to measure tissue oximetry near site ofincision (Inspectra 650) used once before surgery (Day 0) followed by 2times/24 hours from POD 0-5. The investigational device from Crely,Non-Invasive, Low-Risk Experimental Medical Device continuously monitors StO2for 5 days post operation. The device will be carefully attached to the patientin the post operative recovery room only on extubation and under supervision bythe PI or Co-PI. In brief, the sensors are attached to the patient’s skin byadhesive, bilaterally 2 cm from the center of the incision line. The sensorsare subsequently connected to the data collector which is attached to thepatient’s chest to collect data continuously until day 5 post surgery. Data isstored through bluetooth in a pre-assigned laptop computer.Patients experiencestandard perioperative surgical procedures and medication of Medical Clinicincluding antibiotic prophylaxis, pain relief medication for muscle relaxationand anesthetized using Analgesics. Patient’s medical history would be obtainedand monitorinf of vitals on POD0-5, WBC count and CRP before surgery and on POD5would be carried out. Wound characteristics would be assessed daily after POD2,photographs taken and tissue oximetry readings recorded.
**Outcome of the study:** The ability of the sensor developed by Crely in early predictionof surgical site infection would be deciphered.
**Publication:** The findings from the study would be published in a peer reviewedjournal.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- Patients undergoing open abdominal surgeries between the ages of 18 to 80 years 2.
- ASA I to II.
- 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 surgeries 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 Inspectra Total duration is 4 months from start of study. Patients will be monitored with the investigational device till POD5
Trial Locations
- Locations (1)
Sri Ramachandra Institute of Higher Education and Research SRIHER
🇮🇳Chennai, TAMIL NADU, India
Sri Ramachandra Institute of Higher Education and Research SRIHER🇮🇳Chennai, TAMIL NADU, IndiaDr Balaji SinghPrincipal investigator9841330590drbalajicrelystudy2019@gmail.com