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Clinical Trials/CTRI/2024/12/078388
CTRI/2024/12/078388Not yet recruitingPhase 3

DEVELOPMENT OF NOVEL DISINFECTANT SKINPATCH FOR BLOOD DONORS PHLEBOTOMY

Vijit Joon1 site in 1 country50 target enrollmentStarted: January 1, 2025Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Antibacterial and antiseptic effect on the phlebotomy sites.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • HEALTHY INDIVIDUALS WITH NO COMORBIDITIES.
  • NO HISTORY OF DRUG OR SKIN ALLERGIES.

Exclusion Criteria

  • INDIVIDUALS WITH BROKEN SKIN OVER CUBITAL REGIONS.

Outcomes

Primary Outcomes

Antibacterial and antiseptic effect on the phlebotomy sites.

Time Frame: 10 minutes.

Secondary Outcomes

  • Lesser incidences of bacterial contamination of collected blood.(10 minutes.)

Investigators

Sponsor
Vijit Joon
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

VIJIT JOON

Saveetha Medical College

Study Sites (1)

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