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临床试验/CTRI/2024/02/063282
CTRI/2024/02/063282尚未招募4 期

An open label, single-centric, non-randomized clinical study to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in patients having Necrotising soft-tissue infections (NSTI)/ fasciitis - Nil

Datt Mediproducts Pvt Ltd,0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
尚未招募

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1.Adult male or female subjects within the age group of 18 to 70 years (both inclusive).
  • 2.Subject with HbA1c level below 6.5 % (Well-controlled diabetes mellitus)
  • 3.Subject with soft tissue infection caused by trauma, injury, burn, surgery.
  • 4.Subjects with damaged deep layers of your skin that led to necrosis.

排除标准

  • 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.Allergies to any material contained investigational devices.

研究者

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