Health Condition 1: S00-T88- Injury, poisoning and certain other consequences of external causes
Conditions
Interventions
Intervention1: VELVERT (new antimicrobial wound dressing): VELVERT is a non-adherent topical wound dressing which is loaded with antimicrobial formulation of F-10 (Curcuma longa Extract, Phyllanthus e
Sponsors
Datt Mediproducts Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult non-diabetic male and female subjects of the age group between 18 to 70 years. 2. Subjects with second-degree burn wounds 3. Total Body Surface Area of burns 5% to 20% 4. Subjects/ LAR 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 6. All sexually active female subjects of childbearing potential without any clinical evidence of pregnancy
Exclusion criteria
Exclusion criteria: 1. Subjects unwilling or unable to comply with the postoperative visits necessary for data collection. 2. Subjects found positive for HIV 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. Comorbidities which could interfere with clinical evaluations or interpretation of results 6. Subjects with known allergy to the constituents of investigational products/ device. 7. Subjects with immunosuppression, corticosteroids or chemotherapy 8. Subjects with a severe comorbid disorder, not expected to survive more than 12 months. 9. Subjects requiring concomitant use of negative pressure wound therapy (NPWT) on the reference wound 10. Poor adaptivity or seriously ill subjects who cannot finish the observation period 11. Any other condition which, according to the judgment of the investigator, could interfere in the study 12. Subjects with Diabetic foot ulcer and Infected wound.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (i)Evaluation of total wound area (sum of areas of all present wounds on both limbs) has completely closed, compared to baseline (inclusion), on or before the scheduled last visit (Day 24) (ii)Evaluation of time taken for wound closure assessed through Bates-Jensen Wound Assessment Tool and wound photographs at each visitTimepoint: 24 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Comparative evaluation of the number of complete wound closures by day 24 2.Number of subjects reporting relief from pain Comparative evaluation of subjects will record their subjective pain level 3.Number of adverse events either due to dressing material or other causes 4. Assessment of TLC and DLC values. Timepoint: 24 days | — |
Countries
India
Contacts
Public ContactDr Siddharth Pandey
IPGME and R Kolkata
Outcome results
None listed