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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sarat.uppaluri@gmail.com].

  6. 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.

  7. 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.


 
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