1. Velvert Dressing-A novel Anti-Microbial
Wound Dressing
Presenter & PI :- Dr. Anshita Shrivastava
PI:- Prof. Vishal Mago
PI:- Dr. Neeraj Rao
PI:- Dr. Prakher Kesharwani
PI:- Mr. Ashish
“A randomized-controlled, open label, two arm study to evaluate safety and efficacy of a
new antimicrobial wound dressing (VELVERT) compared to Standard dressing in infected wound.”
2. Introduction to VelvertTM
• Soft, non-adherent topical wound dressing.
• Efficacious in absorbing exudates from wounds.
• Easy application on deep and irregular wounds.
• Works well under NPWT.
• Facilitates granulation tissue formation and healing process.
4. How to Apply?
• Step 1: Open Dressing - Extract the sterile dressing from the primary
packing.
• Step 2: Moisten with sterile water or saline. Do not use excessive
quantities as the water present in the dressing cannot be removed, it
will also washout the drug present in the dressing.
• STEP 3: Apply the moist dressing on the infected wound site and
cover with a secondary dressing.
• Note: The dressing needs to be changed every 5th day.
5. How does it Work?
• Has anti-microbial formulation(PLANT DERIVED)
• Gelatin and Chitosan-Polymeric Matrix
• Imparts Anti microbial properties of-Curcuma Longa, Phyllanthus
emblica, Camellia sinensis
6. ANTI MICROBIAL PROPERTY?
• Interacts with cell membrane, binding with metalloproteinases and
inhibition in protein synthesis and DNA replication.
• Effective against Gram +ve, -ve and various superbugs.
• The dressing has claimed to promote cell migration which further
promotes all the steps of wound healing
• Promote cell migration which leads to angiogenesis, wound
contraction, tissue
• Remodeling and re- epithelialization.
7. Commonly Known As
Turmeric/Haldi
• One of the world’s most versatile
spices
• A perennial, rhizomatous, herbaceous
plant
• Native to the Indian subcontinent and
Southeast Asia (20 to 30°C)
10. Efficacy of VELVERTTM with Evidence Based
Medicine
• Title of Study-A randomized-controlled, open label, two arm study to
evaluate safety and efficacy of a new antimicrobial wound dressing
(VELVERT) compared to Standard dressing in infected wound.
• Authors-Dr. Anshita Shrivastava, Prof. Vishal Mago, Dr. Neeraj Rao, Dr.
Prakher Kesharwani
• Facility- Single centre-AIIMS Rishikesh
• CIP ID, Version and Date-DMPL/CIP-01-2020/CT/VV, Version No-2.0,
Date- 14-Jun-2021
• Comparative dressing: Standard Dressing (Paraffin Gauze Dressing)
11. Study Objectives
• Primary Objective :
• To assess the efficacy of a VELVERT compared with Standard dressing
in infected wound.
• Secondary Objectives :
• Assessment of safety based on incidence of wound complications like
infection.
• Assessment of adverse event associated with the new antimicrobial
wound dressing (VELVERT) compared to Standard Dressing (SD).
• Assessment of VELVERT (A new antimicrobial dressing) compared to
Standard dressing based on surgeon’s/ Investigators questionnaire/
review.
12. Study rationale
• Herbal Foundation of the the is well accepted and praised among
Indian population as Safe and better.
• Eficacy and Success of the product needs medical documentation and
review.
13. Study Population
• All the potential subjects, of both genders of 18-70 years of age, all
races, and patients of all socio-economic status who would qualify the
eligibility criteria, will be enrolled in the study.
14. Eligibility Criteria
• Inclusion Criteria:
• 1. Subject with cellulitis, necrotizing fasciitis, venous ulcer, and bed
sores.
• 2. Subjects with Infected wounds with or without trauma.
• 3. Male and female of age group between 18 to 70 years (Adult, Older
Adult).
• 4. Subjects must be able to read and understand informed consent
and sign the informed consent to provide data for the study.
• 5. Subjects who allow their data to be collected for the study at
predefined followup periods.
15. Eligibility Criteria
• Exclusion Criteria:
• 1. Subject unwilling or unable to comply with the follow up visits
necessary for data collection.
• 2. Subject found positive for HIV and HPV.
• 3. Concurrent participation in another clinical trial that involves an
investigational drug or dressing that would interfere with This Study.
• 4. Pregnant females.
16. Exclusion Criteria
• 4. Pregnant females.
• 5. Subjects with osteomyelitis of the underlying bone.
• 6. Subject with Immunosuppression, corticosteroids or
chemotherapy.
• 7. Subject with Diabetic foot ulcer and/or burn.
• 8. Patient with a severe comorbid disorder, not expected to survive
more than 12 months.
17. Endpoints
• Number of dressings and time required (in days) to achieve complete
wound closure. Healing is based on Favorable healing outcome (FHO) at a
time frame of 24 days from the first application of dressing.
• FHO is considered to have occurred in a given patient if all the following
composite endpoints are met:
• i) Total wound area (sum of areas of all present wounds on both limbs) has
decreased, compared to baseline (Screening), by 100% at or before the
scheduled last visit.
• ii) Comparative evaluation of wounds through Bates-Jensen Wound
Assessment Tool and assessment of wound photographs at each visit.
• iii) Comparative evaluation of wound infection during the study period
assessed through TLC and DLC evaluation.
• iv) Visual Analogue scale for pain assessment.
18. Secondary end points
• i) Comparative evaluation of each of the observation used to define
FHO at time frame of 24 days from the first application of dressing.
• ii) Comparative evaluation of the number of complete wound
closures.
• iii) Number of local cares requiring instrumental debridement
(surgical or sharp debridement) in 24 days duration
19. Secondary end points
• iv) Number of subjects reporting relieve from pain Comparative
evaluation of Subject pain level based on a 0-10 Numeric Pain Chart
on each dressing day and its final removal (0=no pain, 10=worst pain
imaginable).
• They will be instructed to share the medication name, dosage, and
number of pills if they are given analgesics for pain relief.
• v) Assessment of infection level Comparative evaluation of Subject for
their infection level based on TLC and DLC values.
20. Study Design
Parameter Credential
Study Type Interventional, comparative
Arm Two arms
Blinding Open label
Study Centre Single Centre
Recruitment Informed consent form
Endpoint Classification Safety and efficacy
Randomization Yes
23. Clinical Operation Plan
• All subjects scheduled for treatment with a new antimicrobial wound dressing
(VELVERT) compared to the traditional standard dressing.
• (SD) would be enrolled in the study after their written consent for participation.
A unique ID will be allotted to each study participants to maintain their identity
confidential. The subjects’ visits will be scheduled based on routine practice.
• Standard dressing (Standard dressing) will be changed every alternate day or as
per the practice (Day 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, & 22) whereas, VELVERT
dressing will be changed every fourth day i.e. on every evaluation visit (day 0,4, 8,
12, 16, & 20) Clinician will be evaluating each wound before and after the
application of VELVERT / Standard dressing.
• It is acknowledged that variations in protocol of care would be expected in
clinical settings. The following activities shall be performed during the schedule
visits: The following activities shall be performed during the schedule visits:
