A non-randomized-controlled, open label, single arm post market clinical study to evaluate effectiveness of a new antimicrobial wound dressing (VELVERT) in Infected Wound.

Datt Mediproducts Pvt Ltd0 个研究点目标入组 35 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•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%.

•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.

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