A randomized-controlled, open label, two arm post market clinical study to evaluate safety and efficacy of a New antimicrobial wound dressing (VELVERT) compared to the Sofra tulle dressing (SD) in infected wound. - VELVERT

Datt Mediproduct Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Inclusion Criteria
•1.Male and female of age group between 18 to 70 years (Adult, Older Adult).
•2.Subjects must be able to read and understand informed consent, and sign the informed consent to provide data for the study.
•3.Subjects who allow their data to be collected for the study at predefined follow-up periods.
•4.Female subject that is willing to take contraceptive pills 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 enrollment.
•5.Subjects suffering from infected wound with size less than 25/30 square centimeter.
•6.Subjects having a traumatic infected wound with duration less than 1 month.

•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.Active foot infections.
•9.Allergies to any material contained investigational devices.
•10.Subjects with burn wounds, DFU, malignant ulcers, tubercular ulcers, leprotic ulcers, gangrenous ulcers, ischemic ulcers, bed sores.
•11.Any other condition which, according to the judgment of the investigator, could interfere in the study.

发起方

Datt Mediproduct Pvt Ltd