| CTRI Number |
CTRI/2026/03/105856 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of Antimicrobial Textiles in Reducing Healthcare-Associated Infections in Post-Operative Liver Transplant ICU: A Quasi-Experimental Study |
|
Scientific Title of Study
|
A Single-Site, Parallel-Arm Quasi-Experimental Pilot Study to Evaluate the Effectiveness of Antimicrobial Textiles in Reducing Healthcare-Associated Infections (HAIs) in Post-Operative Liver Transplant ICUs at MGH Hospital, Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Naimish N Mehta |
| Designation |
Professor And Head Department Of HPB Surgery And Liver Transplantation |
| Affiliation |
Mahatma Gandhi Medical College And Hospital Jaipur |
| Address |
Centre For Digestive Science Sixth Floor Shri Ram Cancer And Superspeciality Centre,
RIICO Institutional Area Sitapura Tonk Road
Jaipur
RAJASTHAN
302022
India |
| Phone |
9811350626 |
| Fax |
|
| Email |
dr.nmehta@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Naimish N Mehta |
| Designation |
Professor And Head Department Of HPB Surgery And Liver Transplantation |
| Affiliation |
Mahatma Gandhi Medical College And Hospital Jaipur |
| Address |
Centre For Digestive Science Sixth Floor Shri Ram Cancer And Superspeciality Centre,
RIICO Institutional Area Sitapura Tonk Road
Jaipur
RAJASTHAN
302022
India |
| Phone |
9811350626 |
| Fax |
|
| Email |
dr.nmehta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Naimish N Mehta |
| Designation |
Professor And Head Department Of HPB Surgery And Liver Transplantation |
| Affiliation |
Mahatma Gandhi Medical College And Hospital Jaipur |
| Address |
Centre For Digestive Science Sixth Floor Shri Ram Cancer And Superspeciality Centre,
RIICO Institutional Area Sitapura Tonk Road
Jaipur
RAJASTHAN
302022
India |
| Phone |
9811350626 |
| Fax |
|
| Email |
dr.nmehta@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College And Hospital Jaipur |
| Address |
RIICO Institutional Area Sitapura Tonk Road Jaipur Rajasthan 302022 India |
| Type of Sponsor |
Private medical college |
|
|
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 Naimish N Mehta |
Mahatma Gandhi Medical College And Hospital |
Centre For Digestive Science Shri Ram Cancer And Superspeciality Centre RIICO Institutional Area Sitapura Tonk Road Jaipur Rajasthan 302022 India
Jaipur
RAJASTHAN |
09811350626
dr.nmehta@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z299||Encounter for prophylactic measures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antimicrobial Hospital Linen |
Hospital Bed Sheets Gowns And Blankets With Embedded Antimicrobial Properties Used In Designated Intensive Care Unit Beds For Post Operative Liver Transplant Patients. The Intervention Will Be Applied Continuously From Intensive Care Unit Admission Until Intensive Care Unit Discharge Or For A Maximum Of Fourteen Days Per Patient. |
| Comparator Agent |
Standard Hospital Linen |
Routine Hospital Bed Sheets Gowns And Blankets Used In Intensive Care Unit Beds As Per Standard Hospital Practice. The Comparator Linen Will Be Used Continuously From Intensive Care Unit Admission Until Intensive Care Unit Discharge Or For A Maximum Of Fourteen Days Per Patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult Patients Admitted To Post Operative Liver Transplant Intensive Care Unit
Expected Intensive Care Unit Stay Of At Least Forty Eight Hours
No Evidence Of Healthcare Associated Infection At Time Of Intensive Care Unit Admission
Patients Receiving Routine Post Operative Liver Transplant Care |
|
| ExclusionCriteria |
| Details |
Patients With Documented Healthcare Associated Infection At Time Of Intensive Care Unit Admission
Patients With Expected Intensive Care Unit Stay Less Than Forty Eight Hours
Use Of Non Study Linen During Intensive Care Unit Stay
Patients Enrolled In Another Interventional Infection Prevention Study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence Of Healthcare Associated Infections Per One Thousand Patient Days In Post Operative Liver Transplant Intensive Care Unit Patients |
Baseline At Intensive Care Unit Admission And Daily Assessment Until Intensive Care Unit Discharge Or Up To Fourteen Days After Admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Distribution Of Type Specific Healthcare Associated Infections Including Central Line Associated Bloodstream Infection Catheter Associated Urinary Tract Infection Ventilator Associated Pneumonia And Surgical Site Infection |
Baseline At Intensive Care Unit Admission And Daily Assessment Until Intensive Care Unit Discharge Or Up To Fourteen Days After Admission |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/03/2026 |
| 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="0"
Months="10"
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
|
Healthcare Associated Infections remain a major cause of morbidity and mortality in post operative liver transplant intensive care units where patients are highly immunocompromised and vulnerable to infections. Environmental reservoirs including hospital linen may contribute to microbial transmission despite routine infection control practices.
This single site parallel arm quasi experimental pilot study aims to evaluate the effectiveness of antimicrobial hospital linen in reducing healthcare associated infections among adult post operative liver transplant patients admitted to the intensive care unit at Mahatma Gandhi Medical College And Hospital Jaipur.
A total of forty eligible patients will be observed across two groups based on fixed intensive care unit bed allocation. One group will receive antimicrobial hospital linen including bed sheets gowns and blankets while the comparator group will receive standard hospital linen used in routine hospital practice. No changes will be made to routine clinical care or infection control protocols.
The primary outcome will be the incidence of healthcare associated infections per one thousand patient days during the intensive care unit stay. Secondary outcomes include distribution of infection types microbial pathogen profile and antimicrobial resistance patterns among confirmed infection cases.
This pilot study will generate real world clinical evidence on the potential role of antimicrobial hospital linen as an environmental infection prevention strategy in high risk transplant intensive care settings in India. |