| CTRI Number |
CTRI/2024/12/078388 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Disinfectant skinpatch to be used for phlebotomy of blood donor with aim of improved disinfection |
|
Scientific Title of Study
|
DEVELOPMENT OF NOVEL DISINFECTANT SKINPATCH FOR BLOOD DONORS PHLEBOTOMY
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIJIT JOON |
| Designation |
Doctor - Post Graduate |
| Affiliation |
Saveetha Medical College |
| Address |
Department of Immunohematology and Blood Transfusion,Room number 550, 5th floor of Hospital building, Saveetha Medical College and Hospital,Saveetha Nagar Chennai 602105
Department of Immunohematology and Blood Transfusion,Room number 550, 5th floor of Hospital building, Saveetha Medical College and Hospital,Saveetha Nagar Chennai 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
06282971445 |
| Fax |
|
| Email |
vijit1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suresh Kumar |
| Designation |
Assistant Professor (Research co-ordinator) |
| Affiliation |
Saveetha Medical College |
| Address |
Department of Immunohematology and Blood Transfusion,Room number 550, 5th floor of Hospital building, Saveetha Medical College and Hospital,Saveetha Nagar Chennai 602105
Department of Immunohematology and Blood Transfusion,Room number 550, 5th floor of Hospital building, Saveetha Medical College and Hospital,Saveetha Nagar Chennai 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
09790651142 |
| Fax |
|
| Email |
sureshiyyapan.sk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VIJIT JOON |
| Designation |
Doctor - Post Graduate |
| Affiliation |
Saveetha Medical College |
| Address |
Department of Immunohematology and Blood Transfusion,Room number 550, 5th floor of Hospital building, Saveetha Medical College and Hospital,Saveetha Nagar Chennai 602105
Department of Immunohematology and Blood Transfusion,Room number 550, 5th floor of Hospital building, Saveetha Medical College and Hospital,Saveetha Nagar Chennai 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
06282971445 |
| Fax |
|
| Email |
vijit1988@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vijit Joon |
| Address |
Saveetrh Medical College,Saveetha Nagar, Thandalam, Chennai Tamil Nadu |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Vijit Joon |
Saveetha Hospital |
Department of Immunohematology and Blood Transfusion,Blood donor Room, 5th floor of Hospital building, Saveetha Medical College and Hospital,Saveetha Nagar Chennai 602105
Kancheepuram
TAMIL NADU |
6282971445
vijit1988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Meducal College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preferrable Blood donors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ethyl alcohol based disinfection prior to blood collection. |
Scrubbing of the phlebotomy sites with ethyl alcohol with the help of cotton balls 10 minutes prior to the blood collection procedure. The alcohol is allowed to dry, which usually takes 45 seconds. The skin bacterial growth after the disinfectant procedure will be taken to compare with the intervention. |
| Intervention |
Skin patches with Nanoparticles prior to blood collection. |
Nanoparticle-based skin patches are to be applied to the phlebotomy site for 30 minutes prior to the procedure. Nanoparticle composites used will be BG-AgrGO/PCL (bioglass-silver functionalized reduced graphene oxide/polycaprolactone), AgBG-GO/PCL (Ag doped bioglass-graphene oxide/polycaprolactone) & AgBG-rGO/PCL (Ag doped bioglass-reduced graphene oxide/polycaprolactone). The nanoparticles are at the strength of 250 micrograms per ml each. The bacterial growth culture of the site will be taken after applying the pacth for the duration, and the results will be compared with the comaprator agent bacterial growth results. The site will also be checked for dermal irritation using the dermal irritation scoring. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
HEALTHY INDIVIDUALS WITH NO COMORBIDITIES.
NO HISTORY OF DRUG OR SKIN ALLERGIES. |
|
| ExclusionCriteria |
| Details |
INDIVIDUALS WITH BROKEN SKIN OVER CUBITAL REGIONS. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Antibacterial and antiseptic effect on the phlebotomy sites. |
10 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lesser incidences of bacterial contamination of collected blood. |
10 minutes. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The study plan is to develop a novel disinfectant patch which uses the disinfectant properties of nanoparticles. The nanoparticles which is being developed are nanoparticles composites of BG-AgrGO/PCL (bioglass-silver functionalized reduced graphene oxide/polycaprolactone) , AgBG-GO/PCL (Ag doped bioglass-graphene oxide/polycaprolactone) & AgBG-rGO/PCL (Ag doped bioglass-reduced graphene oxide/polycaprolactone). The above mentioned composites are being used in the developed dermal patches. The presence of silver will give the antibacterial activity along with the Graphene oxides, both acting against the bacterial cell walls. the reduced graphene oxides with silver should exhibit better antibacterial activity for prolonged duration of time and effectiveness. The dermal patch will be evaluated for their bioactivity and antibacterial properties, followed by its utilisation in the disinfectant purposes for phlebotomy. The dermal patch will be convenient and more effective as compared to currently practiced disinfectant procedures. This product will be tested in the animal study following which the same will be undergoing human trials. |