A randomized, open label, single centre, post market clinical study (PMS) 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.

Datt Mediproducts Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

研究概览

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•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.

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