A randomized, open label, single centre, post market clinical study to evaluate the efficacy and safety of a new antimicrobial wound dressing (VELVERT) compared to Silver Sulfadiazine in the treatment of second degree burn wounds.
- Conditions
- Health Condition 1: S00-T88- Injury, poisoning and certain other consequences of external causes
- Registration Number
- CTRI/2020/12/029698
- Lead Sponsor
- Datt Mediproducts Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (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) <br/ ><br>(ii)Evaluation of time taken for wound closure assessed through Bates-Jensen Wound Assessment Tool and wound photographs at each visitTimepoint: 24 days
- Secondary Outcome Measures
Name Time Method 1.Comparative evaluation of the number of complete wound closures by day 24 <br/ ><br>2.Number of subjects reporting relief from pain <br/ ><br>Comparative evaluation of subjects will record their subjective pain level <br/ ><br>3.Number of adverse events either due to dressing material or other causes <br/ ><br>4.Assessment of TLC and DLC values. <br/ ><br>Timepoint: 24 days