Assessment of the Improvement of Wound Healing Rate and Wound Bioburden With the Combination of Next Science BlastX Antimicrobial Wound Gel and TorrentX Wound Wash
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Wound Size and Volume
研究概览
简要总结
This is a 12-week, single-site, open-label prospective study in adult with a chronic wound diagnosis. Subjects will be randomized in equal numbers to either the control treatment arm, antimicrobial control treatment arm, or Next Science treatment arm and will receive this treatment until the wound is completely healed or they are exited from the study. Subjects will have a weekly in-office debridement visit for up to 12 weeks.
详细描述
This is a 12-week, single-site, open-label prospective study in adult subjects ages 18 years of age and older with a chronic wound diagnosis. There will be 15 completed subjects with up to 18 enrolled. Subjects will be randomized in equal numbers to control group (Mepilex Foam dressing); antimicrobial control group (Mepilex Ag Foam dressing); or Next Science group (TorrentX irrigation, BlastX application, and Mepilex foam dressing). Subjects will receive this treatment until the wound is completely healed or they are exited from the study. Subjects will have a weekly in-office debridement visit for up to 12 weeks. For the Next Science arm, TorrentX will be used during in-office debridement whereas BlastX will be applied once during the in-office visit and then mid-week with dressing change. DNA and plate count analysis will be taken at maximum of 5 time points: baseline/randomization visit, maximum of 3 treatment visits (Visits 3, 5, and 9), and Visit 13/Study exit (if applicable), with cultures taken pre- and post- debridement. Wound measurements will be taken via imaging from Silhouette camera system at every in-clinic visit.
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 chronic wound for more than one month (i.e. chronic)
- •Ulcer must be greater than 1 cm2 to enable biofilm sampling
- •He/she is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period
- •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 chronic wound for less than one month
- •Subjects with a history of bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
- •Subjects whose wound is less than 1 cm2
- •He/she requires endovascular or surgical arterial intervention during the study period
- •Subject with known allergic reaction to the study products ingredients
- •Wound, in the investigator's clinical judgment, is not amenable to management solely with the techniques described in this study (i.e., should be managed in addition with hyperbaric oxygen, vacuum suction, or other adjunctive methods)
结局指标
主要结局
Wound Size and Volume
时间窗: 12 weeks
Significantly Reduced Wound Size and Volume (measured using Aranz Aranz Medical Silhouette Imaging System) at One or More of the Measured Time Points with Next Science Group compared to Control Group(s)
Wound Closure
时间窗: 12 weeks
Significantly Earlier Wound Time to Closure at One or More of the Measured Time Points with Next Science Group compared to Control Group(s)
次要结局
- Bacterial species change(12 weeks)
- Colony Forming Units(12 weeks)
- DNA Quantification(12 weeks)