A randomized open label, compared study to evaluate safety and efficacy of a New antimicrobial wound dressing (VELVERT) with a Standard dressing (SD) in patients with infected wound.

A randomized-controlled, open label, two arm study to evaluate safety and efficacy of a New antimicrobial wound dressing (VELVERT) compared to the Standard dressing (SD) in infected wound.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/12/038436

Enrollment

Registered

2021-12-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject with cellulitis, necrotizing fasciitis, venous ulcer, and bedsores. 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 follow-up periods.

Exclusion criteria

Exclusion criteria: 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. 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.

Design outcomes

Primary

Measure	Time frame
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 assessmentTimepoint: Schedule mentioned in the protocol up to 24 days from the first application of dressing	—

Measure

Time frame

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 assessmentTimepoint: Schedule mentioned in the protocol up to 24 days from the first application of dressing

—

Secondary

Measure	Time frame
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. iv) Number of subjects reporting relive 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 & DLC value.Timepoint: 24 days from the first dressing application.	—

Measure

Time frame

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. iv) Number of subjects reporting relive 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 & DLC value.Timepoint: 24 days from the first dressing application.

—

Countries

India

Contacts

Public ContactDr Pankaj Bablani

All India Institute of Medical Sciences

drvishalm@yahoo.com9812342588

Outcome results