A study to evaluate the safety and effectiveness of a new antimicrobial wound dressing (VELVERT) in patients having Necrotising soft-tissue infections (NSTI)/ fasciitis
- Conditions
- Health Condition 1: M709- Unspecified soft tissue disorder related to use, overuse and pressure
- Registration Number
- CTRI/2024/02/063282
- Lead Sponsor
- Datt Mediproducts Pvt Ltd,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method