A study to evaluate the safety and effectiveness of a new antimicrobial wound dressing (VELVERT) in patients having Necrotising soft-tissue infections (NSTI)/ fasciitis

An open label, single-centric, non-randomized clinical study to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in patients having Necrotising soft-tissue infections (NSTI)/ fasciitis - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/02/063282

Enrollment

Registered

2024-02-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: M709- Unspecified soft tissue disorder related to use, overuse and pressure

Interventions

Intervention1: VELVERT Antimicrobial dressing indicated in the wounds caused due to Necrotising Soft tissue infection. (NSTI): Dressing to be changed every four day or earlier, for 60 days Control Int

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult male or female subjects within the age group of 18 to 70 years (both inclusive). 2. Subject with HbA1c level below 6.5 % (Well-controlled diabetes mellitus) 3. Subject with soft tissue infection caused by trauma, injury, burn, surgery. 4. Subjects with damaged deep layers of your skin that led to necrosis.

Exclusion criteria

Exclusion 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, HBsAg and HCV. 3. Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study. 4. Pregnant females. 5. Subject with Immunosuppression, corticosteroids or chemotherapy. 6. Subject with decision making impairment. 7. Allergies to any material contained investigational devices.

Design outcomes

Primary

Measure	Time frame
A study outcome will be considered if below end points meet. ?Lesion/wound healed by 60 days (2 months) or prior ?Reduction of wound surface area within a time frame of 60 days (2 months). (Change in wound size)Timepoint: 60 days	—

Secondary

Measure	Time frame
? Number of patients achieve a complete wound closure or reduction in wound area by = 50% by 60 days or earlier. (Change in wound area). ? Subject self-assessment of intensity of pain. (Pain scale from 0 to 10) ? Number of adverse events and wound complications either due to dressing material or other causes. (AE reported) ? Number of dressings required to achieve the change in wound size/ wound healing. ? Presence of micro-organism load on the last day of visit (Day 60 or earlier) (SWAB test)Timepoint: 60 days	—

Measure

Time frame

? Number of patients achieve a complete wound closure or reduction in wound area by = 50% by 60 days or earlier. (Change in wound area). ? Subject self-assessment of intensity of pain. (Pain scale from 0 to 10) ? Number of adverse events and wound complications either due to dressing material or other causes. (AE reported) ? Number of dressings required to achieve the change in wound size/ wound healing. ? Presence of micro-organism load on the last day of visit (Day 60 or earlier) (SWAB test)Timepoint: 60 days

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Countries

India

Contacts

Public ContactDr Pankaj Bablani

Datt Mediproducts Pvt Ltd

siddharth.pandey@dattmedi.com9315829298

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026