| CTRI Number |
CTRI/2016/08/007132 [Registered on: 01/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
01/08/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial comparing the risk of local skin infection by preparation of injection site using boiled cotton swab, alcohol swab and no swabbing of visibly clean skin prior to DPT/combination vaccine |
|
Scientific Title of Study
|
A prospective randomized trial to compare the risk of local skin infection by preparation of injection site with boiled cotton swabs, alcohol swabs and with no swabbing of visibly clean skin for DPT/combination vaccines among infants at Advanced Pediatric Center, PGIMER, Chandigarh, 2013-2015 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasneet Kaur |
| Designation |
Student |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh
d/o Karamjeet singh, Quarter no. 161, Housing Board colony, Sangrur. Punjab-148001
Chandigarh
CHANDIGARH
160017
India |
| Phone |
09646950367 |
| Fax |
|
| Email |
jk.jasneet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Saini |
| Designation |
lecturer |
| Affiliation |
National Institute of nursing Education, PGIMER |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160017
India |
| Phone |
|
| Fax |
|
| Email |
sushmadr_saini@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Jasneet Kaur |
| Designation |
Student |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh
d/o Karamjeet Singh, Quarter No. 161, Housing Board colony, Sangrur, Punjab-148001
Chandigarh
CHANDIGARH
160017
India |
| Phone |
09646950367 |
| Fax |
|
| Email |
jk.jasneet@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Jasneet Kaur |
| Address |
NINE,PGIMER, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jasneet Kaur |
Post Graduates Institute of Medical Education & Research, Chandigarh |
Immunization Room No-2422
Department: Advanced Pediatric Center,
Institute: PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9646950367
jk.jasneet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee (intramural) PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Infants getting immunized at Immunization clinic,Advanced Pediatric Center, PGIMER, Chandigarh |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alcohol swabs,
No swabbing |
Comparison of risk of local skin infection by using boiled swabs, alcohol swabs and no swabbing for injection site preparation |
| Comparator Agent |
boiled cotton swabs |
Comparison of risk of local skin infection by using boiled swabs, alcohol swabs and no swabbing for injection site preparation |
|
|
Inclusion Criteria
|
| Age From |
40.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Infants receiving DPT/combination vaccines |
|
| ExclusionCriteria |
| Details |
Infants having visibly soiled injection site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Local skin infection at injection site |
7 days or till infection subsides |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Local skin infection at injection site |
7 days or till the infection subsides |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
We have not published the article anywhere till now, but will publish in future |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective randomized, parallel group trial comparing the risk of local skin infection using boiled cotton swabs, alcohol swabs and no swabbing of visibly clean skin for DPT/combination vaccines among 450 infants that is being conducted in immunization clinic at Advanced Pediatric Center, PGIMER , Chandigarh, India. The primary outcome measured will be local skin infection and each study participant will be followed for 7 days or till the infection subsides. |