| CTRI Number |
CTRI/2011/091/000127 [Registered on: 23/02/2011] |
| Last Modified On: |
22/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [Hand sanitizers] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
DETERMINATION OF THE ANTIMICROBIAL EFFICACY OF TEST PRODUCTS USING THE HEALTH CARE PERSONNEL HANDWASH PROCEDURE |
Scientific Title of Study
Modification(s)
|
DETERMINATION OF THE ANTIMICROBIAL EFFICACY OF TEST PRODUCTS USING THE HEALTH CARE PERSONNEL HANDWASH PROCEDURE |
| Trial Acronym |
HCPHW STUDY |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| HCPHW 01-02/2010- 012-1112 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Vikram Padbidri |
| Designation |
Consultant Microbiologist |
| Affiliation |
Consultant Microbiologist |
| Address |
Jehangir Clinical Development Centre Microbiology Department, 5th Floor, Sohrab Hall, Opposite Jehangir Hospital, 32 Sassoon Road
Jehangir Clinical Development Centre Microbiology Department, 5th Floor, Sohrab Hall, Opposite Jehangir Hospital, 32 Sassoon Road
Pune
MAHARASHTRA
411001
India |
| Phone |
91-9822334543 |
| Fax |
91-20-26059319 |
| Email |
vikram.padbidri@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Vikram Padbidri |
| Designation |
Consultant Microbiologist |
| Affiliation |
Consultant Microbiologist |
| Address |
Jehangir Clinical Development Centre Microbiology Department, 5th Floor, Sohrab Hall, Opposite Jehangir Hospital, 32 Sassoon Road
Jehangir Clinical Development Centre Microbiology Department, 5th Floor, Sohrab Hall, Opposite Jehangir Hospital, 32 Sassoon Road
Pune
MAHARASHTRA
411001
India |
| Phone |
91-9822334543 |
| Fax |
91-20-26059319 |
| Email |
vikram.padbidri@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Vikram Padbidri |
| Designation |
Consultant Microbiologist |
| Affiliation |
Consultant Microbiologist |
| Address |
Jehangir Clinical Development Centre Microbiology Department, 5th Floor, Sohrab Hall, Opposite Jehangir Hospital, 32 Sassoon Road
Jehangir Clinical Development Centre Microbiology Department, 5th Floor, Sohrab Hall, Opposite Jehangir Hospital, 32 Sassoon Road
Pune
MAHARASHTRA
411001
India |
| Phone |
91-9822334543 |
| Fax |
91-20-26059319 |
| Email |
vikram.padbidri@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| GOJO Industries, Inc.
One GOJO Plaza, Akron, Ohio 44311
United States of America
|
|
Primary Sponsor
Modification(s)
|
| Name |
GOJO Industries Inc |
| Address |
One GOJO Plaza, Akron, Ohio 44311, United States of America |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Jehangir Clinical Development Centre |
JCDC Jehangir Hospital Premises 32 Sassoon Road Pune 411001 |
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vikram Padbidri |
Jehangir Clinical Development Centre |
JCDC Microbiology Department 5th Floor Sohrab Hall Opposite Jehangir Hospital 32 Sassoon Road
Pune
MAHARASHTRA |
91-9822334543
91-20-26059319
vikram.padbidri@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hirabai Cowasji Jehangir Medical Research Institute and Jehangir Clinical Development Centre Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Human volunteers in good general health free of dermatoses, cuts, lesions, hangnails, or other skin disorders on the hands and forearms |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
P&G Antibacterial Safeguard liquid bulk soap, EcoLab DigiClean Antibacterial Foam Handwash, Kay Fortress Antibacterial Foam Handwash, DEB Antibacterial Foam Handwash, DCT instant hand sanitizer gel, EcoLab Sanigizer Foam, DEB HIS, Kay Actigel HIS, Byotrol Assure |
For Leave on: 50 ml/ volunteer For Rinse off: 60 pumps/volunteer. For wipes: 10 wipes/ volunteer. Study Duration: 4- 6 hours/volunteer. |
| Intervention |
PURELL Original, Green PURELL, PURELL 70, PURELL 70 HE Gel, PURELL 70 HE Foam, PURELL Skin Nourishing Foam, BAK HIS prototype, MICRELL Foam, PURELL Foam, Woodwards Handclens, PURELL VF481, AV Foam Prototype, HAF, Hibiclens, PROVON Blue Foam, PROVON Reformulation #1, PROVON Reformulation #2, LCTCS Foam Handwash (5400-540) |
For Leave on: 50 ml/ volunteer
For Rinse off: 60 pumps/volunteer.
For wipes: 10 wipes/ volunteer.
Study Duration: 4- 6 hours/volunteer. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
Volunteers may be of either sex, at least eighteen, but not more than seventy years of age, and of any race.
Volunteers must possess both hands.
Volunteers must be free of dermatoses, cuts, lesions, hangnails, or other skin disorders on the hands and forearms.
Volunteers must not have used topical or systemic antimicrobials, antibiotics, or steroids for the one week pre-test conditioning period and must agree to abstain from these materials until the completion of the study.
Volunteers must be in good general health.
Volunteers must have read and signed an Informed Consent Form, and List of Restricted Products.
|
|
| ExclusionCriteria |
| Details |
Exposure of ungloved hands and forearms to antimicrobial agents, medicated soaps, medicated shampoos, hair mousses, or medicated lotions, or use of biocide-treated pools or hot tubs during the seven day pre-test conditioning period or on the single test day.
Exposure of ungloved hands or forearms to strong detergents, solvents, or other irritants during the seven day pre-test conditioning period or on the single test day.
Use of systemic or topical antibiotic medications during the seven day pre-test conditioning period or on the single test day.
Known allergies to latex (rubber), alcohol, or to common antibacterial agents found in soaps, lotions, or in ointments, particularly ethanol or chlorhexidine gluconate, or topical antibiotic ointments (e.g., Neosporin® [neomycin/bacitracin/polymyxin B]).
Knowledge of diagnosis of a physical condition, such as asthma, diabetes, hepatitis, an organ transplant, AIDS (or HIV positive), any immunocompromising disease, mitral valve prolapse, or a requirement to take antibiotics prior to dental procedures (verbal confirmation is acceptable)
Pregnancy, plans to become pregnant within the pre-test and test periods of the study, or nursing a child.
Any active skin rashes or breaks in the skin of hands or forearms.
A currently active skin disease or inflammatory skin condition, including contact dermatitis.
Participation in a clinical study in the past thirty days or current participation in another clinical study.
Any medical condition or use of any medications that, in the opinion of the Investigator, should preclude participation.
Unwillingness to fulfill the performance requirements of the study.
|
|
Method of Generating Random Sequence
Modification(s)
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
Modification(s)
|
An Open list of random numbers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To determine the antimicrobial effectiveness of various test products for use as Health Care Personnel Handwashes using indicator microorganism Serratia marcescens for hand contaminations. Between 8 to 24 volunteers is tested using each test configuration over eleven consecutive hand contaminations, the first followed by baseline sample and the remaining ten by product applications, with microbial samples taken after product applications one, three, seven, and ten. |
Critical indices are a two log10 reduction at wash 1 and a three log10 reduction at wash 10. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1000"
Sample Size from India="1000"
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
Modification(s)
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
28/02/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/02/2011 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The purpose of this study is to determine the antimicrobial effectiveness of various test products for use as Health Care Personnel Handwashes. The indicator microorganism used for hand contaminations will be Serratia marcescens. Volunteers will be tested using each test configuration over the course of eleven consecutive hand contaminations, the first followed by a sample for baseline, and the remaining ten by product applications, with microbial samples taken after product applications one, three, seven, and ten. A volunteer may be tested for more than one product as long as there is a gap of one month between two testings. |