A Six Month Randomized Open-Label Trial of Pressure Ulcer Healing With Microcyn® Skin and Wound Care With Preservatives Versus Sterile Saline in Adult Spinal Cord Injury Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline
研究概览
简要总结
The purpose of this study is to test how well Microcyn™ works on Stage 3 and Stage 4 pressure ulcers compared to sterile saline among persons with spinal cord injury.
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
- •Age > 17 years
- •Persons with spinal cord injury
- •Having Stage III/IV pressure ulcer(s)
- •Able to fulfill all obligations of the study
排除标准
- •Pressure ulcers scheduled for surgical closure within 14 days
- •Use of any immunosuppressant medications within 30 days of screening
- •Having conditions that put the subject at significant risk
- •Medically unstable or has a life expectancy of less than 12 months
- •Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days
- •Pregnant women
研究组 & 干预措施
Microcyn
Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily.
干预措施: Microcyn (Drug)
Sterile saline
Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily.
干预措施: Sterile saline (Other)
结局指标
主要结局
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline
时间窗: 20 weeks after baseline
Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline
时间窗: 4 weeks after baseline
Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline
时间窗: 12 weeks after baseline
Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline
时间窗: 8 weeks after baseline
Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.
Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline
时间窗: pressure ulcer size (length x width x depth, cm^3) at baseline
Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline
时间窗: 16 weeks after baseline
Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline
时间窗: 24 weeks after baseline
Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.
次要结局
- Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline(16 weeks after baseline)
- Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline(8 weeks after baseline)
- Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline(20 weeks after baseline)
- Pressure Ulcer Scale for Healing (PUSH) Score(at baseline)
- Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline(4 weeks after baseline)
- Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline(24 weeks after baseline)
- Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline(12 weeks after baseline)
研究者
Yu-ying Chen
Associate Professor
University of Alabama at Birmingham