| CTRI Number |
CTRI/2024/11/077405 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness, in preventing infections, of handwashing duration of 90 seconds with the standard 180 seconds (3 minutes) before performing a procedure of accessing the big neck veins in the body |
|
Scientific Title of Study
|
Comparison of 90 seconds and 180 seconds surgical handwashing times in preventing Central line associated Bloodstream infections in the ED. A randomized control study. CLAPPED HANDS trial (CLABSI Prevention in ED with Hand hygiene durations) |
| Trial Acronym |
CLAPPED HANDS trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarat Chandra Uppaluri |
| Designation |
Consultant in Department of Emergency Medicine |
| Affiliation |
AIG Hospitals |
| Address |
Ground floor, Department of Emergency Medicine, AIG Hospitals, Mindspace road, Gachibowli, Hyderabad, Telangana, India Mindspace road, Gachibowli, Hyderabad Hyderabad TELANGANA 500027 India |
| Phone |
9705758226 |
| Fax |
|
| Email |
sarat.uppaluri@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sarat Chandra Uppaluri |
| Designation |
Consultant in Department of Emergency Medicine |
| Affiliation |
AIG Hospitals |
| Address |
Ground floor, Department of Emergency Medicine, AIG Hospitals, Mindspace road, Gachibowli, Hyderabad, Telangana, India Mindspace road, Gachibowli, Hyderabad
TELANGANA 500027 India |
| Phone |
9705758226 |
| Fax |
|
| Email |
sarat.uppaluri@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sarat Chandra Uppaluri |
| Designation |
Consultant in Department of Emergency Medicine |
| Affiliation |
AIG Hospitals |
| Address |
Ground floor, Department of Emergency Medicine, AIG Hospitals, Mindspace road, Gachibowli, Hyderabad, Telangana, India Mindspace road, Gachibowli, Hyderabad
TELANGANA 500027 India |
| Phone |
9705758226 |
| Fax |
|
| Email |
sarat.uppaluri@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIG Hospitals,
Mindspace road, Gachibowli, Hyderabad, Telangana, India, 500032 |
|
|
Primary Sponsor
|
| Name |
N/A |
| Address |
N/A |
| Type of Sponsor |
Other [None] |
|
|
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 Sarat Chandra Uppaluri |
AIG Hospitals |
Ground floor, Department of Emergency Medicine.
Mindspace road, Gachibowli, Hyderabad, Telangana, India Hyderabad TELANGANA |
9705758226
sarat.uppaluri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Asian Institute of Gastroenterology (IEC-AIG) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Surgical Handwashing time of 90 seconds |
The operator does surgical handwashing for 90 seconds duration before performing central venous catheterization on the patient assigned to this group. |
| Comparator Agent |
Surgical Handwashing time of the recommended 180 seconds (3 minutes) before Central venous catheterization |
The operator performs surgical handwash for 3 minutes or 180 seconds before performing central venous catheterization in the patient assigned to this group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
- All adult patients requiring central line as judged clinically
- Operators willing to participate
- Patients willing to provide consent or have a legal next of kin willing to provide consent |
|
| ExclusionCriteria |
| Details |
- Operators with skin conditions affecting hand hygiene or refusing to participate
- Those patients requiring emergent central line insertion like crashing patients without peripheral venous access
- Patients with already established central line associated infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CLABSI (Central Line Associated Blood Stream Infections) rates per 1,000 central line days |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hand hygiene compliance
Physician satisfaction using Likert scale |
Immediately after procedure |
|
|
Target Sample Size
|
Total Sample Size="1504" Sample Size from India="1504"
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)
|
04/12/2024 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [sarat.uppaluri@gmail.com].
- For how long will this data be available start date provided 01-04-2026 and end date provided 30-03-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Central line-associated bloodstream infections (CLABSI) are a leading cause of morbidity, mortality, and healthcare-associated costs in hospitals worldwide. The emergency department (ED) is a high-risk environment for CLABSI due to the high volume of patients, urgent insertion of central lines, and limited time for healthcare workers to adhere to rigorous infection control practices. Surgical handwashing is a cornerstone of CLABSI prevention, and the World Health Organization (WHO) and Centre for Disease Control and Prevention (CDC) recommend a handwashing time of 2 to 5 minutes to reduce microbial load and prevent infections. However, the practicality of adhering to this duration in fast-paced ED environments has raised concerns. ED healthcare workers often face time constraints, high patient acuity, and limited staffing, making it challenging to allocate at least 3 minutes for handwashing. Most of the studies assessed the efficacy of handwashing duration by culturing the hands. No studies, as per our research evaluated the direct clinical implication comparing different handwashing times. A shorter handwashing time of 90 seconds may offer a more realistic and sustainable solution for ED healthcare workers while maintaining the integrity of infection control practices. This study aims to investigate whether a 90-second surgical handwashing time is non-inferior to the conventional 2 to 5 minutes in preventing CLABSI in the ED setting and see if this shortened duration improves compliance among physicians. By exploring the efficacy of a shorter handwashing time, this study seeks to contribute to the development of more efficient, practical, and evidence-based infection control guidelines for ED healthcare workers.
|