CTRI/2022/12/047886招募中4 期
A prospective randomized open-label study to evaluate the comparative efficacy and safety of AgFix® non-adhesive foam dressing versus standard gauze dressing in patients with grade II pressure ulcers
Dynamic Techno Medicals Private Limited0 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
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Male or female subject over 18?and upto 70 years of age
- •2 Subject with pressure ulcers belonging to stage II (PrU-II) according to the US National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP) guideline
- •3 Subject with at least one pressure ulcer. In case the subject has more than one PrU-II, only the largest diameter ulcer will be assessed.
- •4 Pressure ulcer size of 1-10 cm2 at screening
- •5 Subject who have given written informed consent
排除标准
- •1 Subject with pressure ulcers other than stage II according to the US National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP) guideline
- •2 Subject with terminal situation (life expectancy less than 6?months) or requiring ICU admission
- •3 Subject with history of allergy to materials in the study dressings.
- •4 Subject having ulcers from other aetiologies (tumour, infection, amputation, dehisced surgical, venous, ischaemic, traumatic or diabeticfoot ulcer)
- •5 Subject with pressure ulcer in previously irradiated areas
- •6 Wounds treated with negative pressure therapy
- •7 Subject who is pregnant, parturient, or breastfeeding
- •8 Subject with immunodeficiency, random blood sugar >180 mg/dL, osteomyelitis, peripheral vascular illness or other systemic inflammatory disease
- •9 Subject with active neoplastic lesion treated with radiation or chemotherapy
- •10 Subject requiring MRI (Magnetic Resonance Imaging) examination during the course of the study
- •11 Subject who received an experimental drug or used an experimental study dressing within 30 days prior to the planned start of procedure
- •12 Subject already participating in another clinical study
- •13 Subject unlikely to comply with study procedure or complete the scheduled follow up visit, in the opinion of PI
- •14 Employee of the PI or study center with direct involvement in the proposed study or other studies under the direction of that PI or study center
- •15 Subject with mental disorder, learning disability, or language barrier
- •16 Any confirmed or suspected SARS-CoV-2 virus/variant or COVID-19 disease
- •17 Other indication-based exclusion, in opinion of PI
研究者
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