Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Wound Size Reduction
研究概览
简要总结
This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients diagnosed with a chronic wound. The primary objective is to assess changes in healing rate, by measuring differences in wound area when treating chronic wounds with the Next Science Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At the end of the study period, patients may continue receiving their assigned study treatment provided they have signed the "Continuation of Treatment Informed Consent" and the rational for continuation is documented by the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female 18 years or older
- •Presence of full-thickness wound for more than one month (i.e. chronic)
- •Ulcer must be greater than 1 centimeter in area to enable biofilm sampling
- •NOT a candidate for vascular reconstructive surgery to restore blood flow to the wound
- •Willing to comply with all study procedures and be available for the duration of the study
- •Provide signed and dated informed consent
排除标准
- •Subjects unable to provide signed and dated informed consent
- •Male or female less than 18 years old
- •Presence of a full-thickness wound for less than one month
- •A candidate for vascular reconstructive surgery to restore blood flow to the wound
- •Subjects with bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
- •Subjects who's wound is less than 1 cm precluding adequate wound biofilm sampling
- •Subject with known allergic reaction to the study products
研究组 & 干预措施
Triple Antibiotic Ointment Neosporin
Daily direct application to the wound, covered with conventional dressing. Dressing should be changed daily or as directed by the health care provider.
干预措施: Triple Antibiotic Ointment Neosporin (Drug)
Next Science Wound Gel
Daily direct application to the wound, covered with a conventional non-alginate dressing. Dressing should be changed daily or as directed by the health care provider.
干预措施: Next Science Wound Gel (Device)
结局指标
主要结局
Wound Size Reduction
时间窗: 2, 4, 8 and 12 weeks
次要结局
- Wound Closure(2, 4, 8 and 12 weeks)