Combination of Taliderm® and VAC for Treatment of Pressure Ulcers - a Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
Background: The wound healing promoting effect of negative wound pressure therapies (NWPT) takes place at the wound foam interface. Implementation of bioactive substances at this site represents a major research area for the development of future NWPT devices.
Methods: Wound healing kinetics of pressure ulcers treated by vacuum assisted closure devices with or without the implementation of a thin interface of poly-N-acetyl glucosamine nanofibers (sNAG) was studied in a prospective randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Ischial/sacral Pressure ulcer between 4 and 15cm diameter
- •Greater than or equal to 18 years of age
- •Ability to obtain informed consent
排除标准
- •Connective tissue disorders
- •Immunosuppression, Hemodialysis, Steroids
- •Pregnancy
研究组 & 干预措施
wound dressing with VAC
After wound debridement wounds are treated for 2 weeks with VAC dressing alone
干预措施: wound dressing with VAC (Procedure)
wound dressing with VAC and sNAG without antiaggregation
In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG
干预措施: wound dressing with VAC and sNAG without antiaggregation (Other)
wound dressing with VAC and sNAG under Antiaggregation
In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG
干预措施: wound dressing with VAC and sNAG without antiaggregation (Other)
wound dressing with VAC and sNAG under Antiaggregation
In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG
干预措施: wound dressing with VAC and sNAG under Antiaggregation (Drug)
wound dressing with VAC and sNAG under Antiaggregation
In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG
干预措施: wound dressing with VAC (Procedure)
wound dressing with VAC and sNAG without antiaggregation
In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG
干预措施: wound dressing with VAC (Procedure)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: up to 1 year
Wound surface area increase, respectively decrease as a measure of the effect of the studied devices on pressure ulcer healing
时间窗: up to 1 year
次要结局
- Wound Healing characteristics(up to 1 year)