| CTRI Number |
CTRI/2023/09/058027 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
29/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Early detection Of post-operative infection after abdominal surgery |
|
Scientific Title of Study
|
An academic study of the investigation of digital biomarkers for early detection of surgical site infections |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dharini Prasad |
| Designation |
Post Graduate in General Surgery |
| Affiliation |
Institute of General Surgery |
| Address |
Institute of General Surgery,
Rajiv Gandhi Govt. General Hospital,
Madras Medical College,
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
|
| Fax |
|
| Email |
pi.mmcstudy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Kawarat |
| Designation |
Assistant Professor |
| Affiliation |
Institute of General Surgery |
| Address |
Institute of General Surgery,
Rajiv Gandhi Govt. General Hospital,
Madras Medical College,
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
8920984970 |
| Fax |
|
| Email |
hugvikas@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF DR PS SHANTHI MS |
| Designation |
Professor of Surgery S2 unit |
| Affiliation |
Institute of General Surgery |
| Address |
Institute of General Surgery,
Rajiv Gandhi Govt. General Hospital,
Madras Medical College,
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
|
| Fax |
|
| Email |
drpsshanthimmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Crely Healthcare Private Limited is providing experimental devices at no cost to the study.
Address:
Crely Healthcare Private Limited
New No 38/4, Old No 74/4,Second Floor,
Bazullah Road,Thyagaraya Nagar,
Chennai,
Tamil Nadu,600017
Corporate Identity Number: U85100TN2021FTC146194 |
|
|
Primary Sponsor
|
| Name |
Madras Medical College |
| Address |
Institute of General Surgery
Rajiv Gandhi Govt. General Hospital
Madras Medical College
Chennai 600 003
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Crely Healthcare Private Limited |
New No 38/4, Old No 74/4,Second Floor,
Bazullah Road,Thyagaraya Nagar,
Chennai,Tamil Nadu,600017 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dharini Prasad |
Rajiv Gandhi Govt. General Hospital |
Building: Tower Block II
Floor: 4th Floor
Department: Surgery S2 unit
Division: Institute of General Surgery
Rajiv Gandhi Govt. General Hospital
3 Grand Southern Trunk Rd,
Park Town,
Chennai,
Tamil Nadu
India
600003
Chennai
TAMIL NADU |
8920984970
pi.mmcstudy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Madras Medical College |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator |
Standard Post-operative care
Pre-operative
1.Medical, surgical history, and medication history will be recorded to determine eligibility
2.Demographics and vitals will be documented; physiological data collected as a part of their routine procedure
3. Complete physical examination will be performed to preclude any local or systemic infections. Standard pre-operative procedure will be followed and will include routine blood and serological investigations, prophylactic antibiotics, and pre-op skin preparation per the norm. Patient’s vitals including SpO2 will be monitored.
Perioperative
1.Patient vitals will be monitored throughout the procedure
2.Duration of surgical procedure and other perioperative details will be documented
Post-Operative Day (POD) 0
1.Patient will be assessed for adverse events directly related to the medical condition or surgery.
2.Crely’s non-Invasive, low-risk experimental medical device sensor will be carefully attached to the patient in the post-operative recovery room under supervision by the PI or Co-PI. The sensors will be attached to the patients skin
3.The device will continuously monitor the wound parameters of local tissue oxygen saturation (StO2), Bio impedance (BioZ), and temperature.
4.Patient’s vitals (HR, BP, body temperature, SpO2) will be monitored four times daily.
5. For subjects enrolled to the control arm of the study, the device will continue to operate as planned. There will be no feedback on the device data to the clinician or the study team.
|
| Intervention |
Intervention |
Standard Post-Operative Care with additional early warning from the digital biomarkers that are indicative of an aberrant wound healing.
Pre-operative
1.Medical, surgical history, and medication history will be recorded to determine eligibility
2.Demographics and vitals will be documented; physiological data collected as a part of their routine procedure
3. Complete physical examination will be performed to preclude any local or systemic infections. Standard pre-operative procedure will be followed and will include routine blood and serological investigations, prophylactic antibiotics, and pre-op skin preparation per the norm. Patient’s vitals including SpO2 will be monitored.
Perioperative
1.Patient vitals will be monitored throughout the procedure
2.Duration of surgical procedure and other perioperative details will be documented
Post-Operative Day (POD) 0
1.Patient will be assessed for adverse events directly related to the medical condition or surgery.
2.Crely’s non-Invasive, low-risk experimental medical device sensor will be carefully attached to the patient in the post-operative recovery room under supervision by the PI or Co-PI. The sensors will be attached to the patients skin
3.The device will continuously monitor the wound parameters of local tissue oxygen saturation (StO2), Bio impedance (BioZ), and temperature.
4.Patient’s vitals (HR, BP, body temperature, SpO2) will be monitored four times daily.
5.For subjects enrolled to the control arm of the study, the device will continue to operate as planned. There will be no feedback on the device data to the clinician or the study team.
6. For subjects enrolled to the intervention arm, the device will be programmed to predict a wound risk score at that point in time, in the subsequent 24 hours, and the subsequent 48 hours by means of a dashboard in display. Alarms will be activated if the risk index exceeds the normal permissible range and will pre-empt the clinician to take an early action based on the calculated score displayed on the dashboard.
Duration of Intervention: 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are undergoing elective or emergency laparotomy or undergoing gastrointestinal surgery for benign and malignant conditions
2.18-80 years of age at the time of admission
|
|
| ExclusionCriteria |
| Details |
1.Subjects who are diagnosed of communicable diseases and are a risk for biohazard
2.Subjects with preoperative sepsis
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To collect objective and quantifiable digital biomarker data continuously from the surgical site of patients who have undergone elective or emergency laparotomy, to develop early warning algorithms to detect and predict the likelihood of SSIs |
Day of Surgery to 30 days post-discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Remotely monitor the surgical wound during the post-operative period using a novel medical device |
Day of Surgery to Discharge from hospital |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pi.mmcstudy@gmail.com].
- For how long will this data be available start date provided 01-10-2024 and end date provided 30-09-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Surgical site infections (SSIs) account for 20% of the estimated two million nosocomial infections. Although the global estimates of SSI are diverse, studies in India have consistently shown higher rates ranging from 23% to 38%. The incidence of SSI is as high as 15-25% after an abdominal surgery as compared to other surgeries and is largely dependent on the level of contamination during surgery. Suchitra et al conducted a prospective study in India and observed that surgeries such as gastrectomy, hysterectomy, cholecystectomy and appendectomy were associated with a higher risk of SSI. Jacobs et al reported a 30-day readmission of 22% for patients undergoing major abdominal surgery, with 47% of readmissions occurring within 1 week of discharge.As the symptoms and signs of SSIs mimic ‘normal’ recovery, they are detected usually after the infection is firmly established. This leads to complications such as, the need for re-entry of the wound; when severe, this can lead to sepsis, organ failure, and death. The prevalence of SSI is often underestimated because SSIs frequently present after the patient is discharged. We hypothesize that the early warning risk scores calculated using the novel medical device is linked to the pathobiology of wound healing and will be predictive of SSIs in patients who have undergone elective or emergency laparotomy or gastrointestinal surgery for benign or malignant disease.
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