Health Condition 1: L00-L08- Infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: VELVERT: It is an Antimicrobial wound dressing used in infected wounds
The duration of dressing application would be 24 days from the first application of dressing.
Control Intervention
Sponsors
Datt Mediproducts Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female of age group between 18 to 60 years (Both included). 2. Subject/LAR must be able to read and understand informed consent, and sign the informed consent to provide data for the study. 3. Subject/LAR who allow their data to be collected for the study at predefined follow-up periods. 4. Female subject that is willing to take contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least twelve (12) months prior to enrolment. 5. Subjects suffering from infected wound with = 5 cms to = 25cms. 6. Subjects having a traumatic infected wound with duration less than 1 month. 7. Subjects having HbA1c =7%.
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. Subject with a severe comorbid disorder, not expected to survive more than 12 months. 8. Allergies to any material contained investigational devices. 9. Subjects with burn wounds, DFU, malignant ulcers, tubercular ulcers, leprotic ulcers, gangrenous ulcers, ischemic ulcers, bed sores. 10. Any other condition which, according to the judgment of the investigator, could interfere in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 scheduled visit. iii.Evaluate bacterial load Assessment (Day 0), and on the last day (Day 24). Timepoint: 24 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Comparative evaluation of wound infection during the study period assessed through TLC and DLC evaluation. ii. Comparative evaluation of the number of complete wound closures. iii. Number of subjects reporting relive from pain Comparative evaluation of Subject pain level based on a 0 to 10 Numeric Pain Chart on each dressing day and its final removal (0 for No pain, 10 for 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.Timepoint: 24 days | — |
Countries
India
Contacts
Public ContactDr Pankaj Bablani
Yashwantrao Chavan Memorial Hospital
Outcome results
None listed