Open, Non Comparative, Single Center Investigation Exploring the Clinical Utility of a New Silver Gel for Use on Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.
研究概览
简要总结
This investigation will be conducted in the US as a single-center study to evaluate in total 10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds.
详细描述
Both inpatients and outpatients will be included in this study. The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Both genders with an age >18 years
- •Subjects with chronic wounds < 1 year chronicity that are assessed as having localized infection or inflammation (i.e. not felt to have systemic involvement) as indicated by the presence of at least 2 of the following clinical signs of infection:
- •Increased drainage
- •Foul odor
- •Subject's wounds may also present with:
- •presence of eschar or slough that needs to be treated prior to normal standard of care OR
- •A need for topical care after debridement
- •Study site to include only ONE wound to be treated
排除标准
- •Presence of fever with 2 or more clinical signs of infection that in the opinion of the investigator is indicative of a more systemic type infection.
- •Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days
- •Wound > 1 year old
- •Wound > 10 cm x 10 cm (l x w)
- •Wound > 6 cm deep
- •Use of chemical/enzymatic and biological debridement within 7 days of investigation start
- •Necrotizing wounds
- •Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment.
- •Subjects with poorly controlled diabetes mellitus (as judged by the investigator).
- •Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisone/day or equivalent.
- •Known allergy/hypersensitivity to any of the components of the investigation products.
- •Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including subjects totally confined to bed.
- •Participation in other clinical investigation(s) within 1 month prior to Previously randomized to this investigation
研究组 & 干预措施
Device, dressing
Normlgel Ag is an opaque, amorphous hydrogel containing a high water content, water soluble polymer chains and an antimicrobial silver compound.
干预措施: Normlgel Ag (Device)
结局指标
主要结局
Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.
时间窗: 4 weeks
Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.
次要结局
- Pain Upon Application of Investigational Product.(4 weeks)
- Infection Assessment(4 weekks)