| CTRI Number |
CTRI/2024/04/066362 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Impact of various interventions in reducing surgical site infections in hospital care settings |
|
Scientific Title of Study
|
Impact of multipronged interventions targeting healthcare professionals in reducing surgical site infections and identifying the challenges in adoption of these interventions- an implementation research |
| 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 Rachna Rohilla |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
B-308, Department of Pharmacology, Medical College Building, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9876238583 |
| Fax |
|
| Email |
rachna.rohilla20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachna Rohilla |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
B-308, Department of Pharmacology, Medical College Building, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9876238583 |
| Fax |
|
| Email |
rachna.rohilla20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachna Rohilla |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
B-308, Department of Pharmacology, Medical College Building, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9876238583 |
| Fax |
|
| Email |
rachna.rohilla20@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research (ICMR), New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rachna Rohilla |
All India Institute of Medical Sciences, Bathinda |
All India Institute of Medical Sciences, Bathinda
Bathinda
PUNJAB |
9876238583
rachna.rohilla20@gmail.com |
| Dr Sandeep Kaushal |
Dayanand Medical College, Ludhiana |
Dayanand Medical College, Ludhiana
Ludhiana
PUNJAB |
9876238583
skaushal1@yahoo.com |
| Dr Robin Kaushik |
Government Medical College and Hospital, Sector-32, Chandigarh |
Government Medical College and Hospital, Sector-32, Chandigarh
Chandigarh
CHANDIGARH |
9876238583
robinkaushik@yahoo.com |
| Dr Syed Shariq Naeem |
Jawaharlal Nehru Medical College, AMU |
Jawaharlal Nehru Medical College (JNMC), AMU, Uttar Pradesh
Aligarh
UTTAR PRADESH |
9876238583
syedshariq1@gmail.com |
| Dr Ashish Kakkar |
Postgraduate Institute of Medical Education and Research, Chandigarh |
• Postgraduate Institute of Medical Education and Research, Chandigarh (PGIMER Chandigarh)
Chandigarh
CHANDIGARH |
9876238583
drashishkakkar@gmail.com |
| Dr Niti Mittal |
Postgraduate Institute of Medical Sciences, Rohtakl |
Postgraduate Institute of Medical Sciences, UHS, Rohtak
Rohtak
HARYANA |
9876238583
drniti.mittal@gmail.com |
| Dr Sanchit Chaudhary |
Radhakrishnan Government Medical College, Hamirpur |
Dr Radhakrishnan Government Medical College, Hamirpur, Himachal Pradesh (H.P)
Hamirpur
HIMACHAL PRADESH |
9876238583
surgeonsanchit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bathinda |
Approved |
| Institutional Ethics Committee, Dayanand Medical College, Ludhiana |
Submittted/Under Review |
| Institutional Ethics Committee, GMCH-32, Chandigarh |
Submittted/Under Review |
| Institutional Ethics Committee, JNMC, AMU |
Submittted/Under Review |
| Institutional Ethics Committee, PGIMER Chandigarh |
Approved |
| Institutional Ethics Committee, PGIMS Rohtak |
Approved |
| Institutional Ethics Committee, Radhakrishnan Government Medical College, Hamirpur |
Submittted/Under Review |
|
|
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 |
Baseline SSI and practice |
The baseline data on practice and rate of SSI for various surgeries will be comparator of the study. The design is quasi experimental pre-post design. Each site baseline data will act as their own control/comparator. |
| Intervention |
Multipronged interventions |
The multipronged interventions will be co-developed in the first phase of the study. These interventions will be package of various (not limited to) behavioral, system, practice, antimicrobial related or administrative interventions. Once developed they will be implemented to see the effect on rate of surgical site infections. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Surgical patients undergoing elective or emergency procedure (open or laparoscopic) under general surgery, neurosurgery, orthopedics, pediatric surgery, plastic surgery, urology. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The rate of surgical site infection till 30 days after surgery (90 days if implant) using CDC definition of SSI in pre-intervention versus post-intervention phase for clean, clean-contaminated and contaminated surgeries |
The rate of surgical site infection till 30 days after surgery (90 days if implant) using CDC definition of SSI in pre-intervention versus post-intervention phase for clean, clean-contaminated and contaminated surgeries |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The number of ICU admissions averted and number of readmissions averted in clean, clean-contaminated and contaminated surgeries by adoption of multipronged interventions |
30 days after surgery |
| The length of index hospital admission in pre-intervention and intervention phase for clean, clean-contaminated and contaminated surgeries. |
post-operatively |
| The antimicrobial consumption indicators (Days of therapy) in the pre-intervention and intervention phase for clean, clean-contaminated and contaminated surgeries |
peri-operative period |
| The percentage of patients receiving single dose of antimicrobial prophylaxis in the pre-intervention and intervention phase for clean, clean-contaminated and contaminated surgeries |
Peri-operative period |
| The percentage of patients receiving prolonged antimicrobial prophylaxis in the pre-intervention and intervention phase for clean, clean-contaminated and contaminated surgeries |
Peri-operative period |
| The percentage of irrational combinations of drugs (double gram positive, double gram negative or double anaerobic coverage) for surgical antimicrobial prophylaxis in the pre-intervention and intervention phase for clean, clean-contaminated and contaminated surgeries |
Peri-operative period |
| The number of deaths prevented in clean, clean-contaminated and contaminated surgeries by adoption of multipronged interventions |
30 days after surgery |
| Acceptance of these multipronged interventions and challenges in their implementation by healthcare professionals |
Peri-operative |
|
|
Target Sample Size
|
Total Sample Size="6860"
Sample Size from India="6860"
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 4 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is "Impact of multipronged interventions targeting healthcare professionals in reducing surgical site infections and identifying the challenges in adoption of these interventions."Multicentric study (7 sites in India) with mixed method design. Phase-I will involve formative research and practice analysis. Phase-II will involve co-development of the multipronged interventions. Phase-III will involve deployment of the multipronged interventions and process evaluation. Phase-IV will involve impact assessment and dissemination of results. |