Randomized Double-Blind Controlled Clinical Trial Comparing Sodium Hypochlorite Antiseptic to Normal Saline in Reducing Bioburden in Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Reduction in bacterial bioburden
研究概览
简要总结
The study is a randomized double-blind controlled clinical trial designed to compare the ability of NaOCl to NSS in the reduction of bacterial burden in nonhealing acute and chronic wounds.
详细描述
The study is a randomized double-blind controlled clinical trial designed to compare the ability of NaOCl to NSS in the reduction of bacterial burden in nonhealing acute and chronic wounds. Using the generally accepted surrogate endpoint of surface area reduction at 4 weeks, the study will also compare the healing of subjects utilizing NaOCl vs. NSS.
After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MiX). The subject is then randomized to one of two arms: target ulcer cleansed with NaOCl or NSS. After cleansing the wound a second MiX is performed. The subject is given a four-week supply of either NaOCl or NSS.
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
- Double (Participant, Investigator)
盲法说明
This protocol is double-blinded. Subjects will be randomized 1:1 to have their wound cleansed with either NSS or NaOCl. Unblinded staff will prepare the solutions for the two arms the morning of the day of enrollment. NSS and NaOCl will be placed in labeled containers consistent with the randomization scheme. NaOCl has a faint odor of chlorine. In order to maintain the blind the containers will have chlorine placed on the outside of bottom of the container and in the treatment room an open container of chlorine bleach will be safely positioned as to avoid injury to subjects and research personnel, but close enough to provide a mild chlorine smell in the room. Finally, the unblinded research staff will provide the subject with their 4-week supply of NSS or NaOCl to take home.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with acute or chronic wounds that have been present for a minimum of 4 weeks.
- •A signed and dated informed consent form.
- •Subject is willing and able to comply with instructions and scheduled visits.
排除标准
- •The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.
- •The subject's wound has not been present for at least 4 weeks.
研究组 & 干预措施
Experimental
Target ulcer cleansed with NaOCl. After cleansing the wound a second MiX is performed. The subject is given a four-week supply of NaOCl.
干预措施: AnaSept® (Device)
Control
Target ulcer cleansed with NSS. After cleansing the wound a second MiX is performed. The subject is given a four-week supply of NSS.
干预措施: NSS (Other)
结局指标
主要结局
Reduction in bacterial bioburden
时间窗: 4 weeks
The reduction in bacterial bioburden as determined by the MolecuLight Procedure (MiX) between normal saline (NSS) and sodium hypochlorite (NaOCl) wound washing.
次要结局
- Adverse Events(4 weeks)
- Healing rate(4 weeks)
- Pain Score (PEG)(4 weeks)