| CTRI Number |
CTRI/2021/02/031351 [Registered on: 17/02/2021] Trial Registered Prospectively |
| Last Modified On: |
16/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Testing Medical Device (Sensor) to predict infection |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing a Medical Device to predict surgical site infection |
|
Scientific Title of Study
|
Pre-Pilot Study of Digital Biomarkers to detect Surgical Site Infection Post-Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Balaji Singh |
| Designation |
Professor and Head General Surgery |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (SRIHER) |
| Address |
Office of the Dean (Students), Establishment Section, Medical College Building, Sri Ramachandra Institute of Higher Education and Research (SRIHER)
No:1, Ramachandra Nagar,
Porur, Chennai
No:1, Ramachandra Nagar,
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9841044913 |
| Fax |
|
| Email |
drbalajicrelystudy2019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena Iyer |
| Designation |
Consultant Clinical Research |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (SRIHER) |
| Address |
Clinical Research Division Room-04, Dental College Basement, Sri Ramachandra Institute of Higher Education and Research (SRIHER)
No:1, Ramachandra Nagar,
Porur, Chennai
No:1, Ramachandra Nagar,
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9841330590 |
| Fax |
|
| Email |
srmcclinicalresearch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meena Iyer |
| Designation |
Consultant Clinical Research |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (SRIHER) |
| Address |
Clinical Research Division, Room-04, Dental College Basement, Sri Ramachandra Institute of Higher Education and Research (SRIHER)
No:1, Ramachandra Nagar,
Porur, Chennai
No:1, Ramachandra Nagar,
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9841330590 |
| Fax |
|
| Email |
srmcclinicalresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Crely Healthcare will be providing the investigational device. |
|
|
Primary Sponsor
|
| Name |
Crely Healthcare Ltd |
| Address |
Crely Healthcare Pte. Limited
7 Temasek Boulevard
#12-07 Suntec Tower One
Singapore 038 987 |
| Type of Sponsor |
Other [Healthcare company developing a medical device SaaS platform] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balaji Singh |
Sri Ramachandra Institute of Higher Education and Research SRIHER |
No1 Ramachandra Nagar
Porur Chennai 600116
Chennai
TAMIL NADU |
9841330590
drbalajicrelystudy2019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing open abdominal surgeries between the ages of 18 to 80 years
2. ASA I to II
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/03/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The direct results of this clinical study would be published by Crely HEalthcare along with the PI (Dr. Balaji Singh) in a peer reviewed journal after completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Brief Summary of the Study: Objective: The
objective of this study is to collect digital biomarker (tissue oxygen
saturation) measurements from patients using a near-infrared spectrophotometry
device to explore early warning for surgical site infection. Methodology: Crely has developed a sensor for continuous monitoring of tissue
saturation of Oxygen (StO2) that has higher potency in early prediction of
surgical site infection. About 30 patients undergoing open abdominal surgeries
between the ages of 18 to 80 years would be enrolled in the study. The study
involves use of a gold standard device to measure tissue oximetry near site of
incision (Inspectra 650) used once before surgery (Day 0) followed by 2
times/24 hours from POD 0-5. The investigational device from Crely,
Non-Invasive, Low-Risk Experimental Medical Device continuously monitors StO2
for 5 days post operation. The device will be carefully attached to the patient
in the post operative recovery room only on extubation and under supervision by
the PI or Co-PI. In brief, the sensors are attached to the patient’s skin by
adhesive, bilaterally 2 cm from the center of the incision line. The sensors
are subsequently connected to the data collector which is attached to the
patient’s chest to collect data continuously until day 5 post surgery. Data is
stored through bluetooth in a pre-assigned laptop computer.Patients experience
standard perioperative surgical procedures and medication of Medical Clinic
including antibiotic prophylaxis, pain relief medication for muscle relaxation
and anesthetized using Analgesics. Patient’s medical history would be obtained
and monitorinf of vitals on POD0-5, WBC count and CRP before surgery and on POD5
would 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 prediction
of surgical site infection would be deciphered.
Publication: The findings from the study would be published in a peer reviewed
journal. |