NCT03522714已完成不适用
A Prospective, Randomized Controlled Trial Evaluating the Effectiveness of the Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System in the Acute Post-Operative Management of Surgically Closed Pressure Ulcers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery
研究概览
简要总结
The primary objective is to compare the efficacy of the FIS on closure rate to the AFB after 2 weeks of operative debridement and closure.
详细描述
Secondary Objectives:
- Compare the complication rate in each treatment group during the acute postoperative period (2 weeks).
- Comparisons of the inflammatory and bacterial microbiomes of pressure ulcers following surgical therapy.
- Comparisons of baseline patient characteristics and their relationship to both early and late pressure ulcer recurrence, and complication rates.
- Assessment of outcomes and complications associated with flap technique and surgeon guided descriptions of the operative closure.
- Compare the absolute costs associated with the FIS System against AFB system.
- Compare the acceptance of each system by subjects and nursing staff, including the parameter of patient comfort at 7 and 14 days postoperative.
- Assessing the incidence of complications and additional treatments needed following the two week study period.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •will be admitted as an inpatient
- •is ≥ 18 years of age and ≤ 85 years of age at time of consent
- •is able to provide his/her own informed consent
- •is deemed by the investigators to be reasonably compliant
- •has a pressure ulcer meeting criteria for stage III or IV
- •has not participated in a clinical trial within the past 30 days
- •has a 30-day wound history available if the wound has been previously treated
排除标准
- •has a life expectancy of < 12 months
- •is not healthy enough to undergo surgery for any reason
- •has a history of radiation therapy
- •is, in the opinion of the investigator, noncompliant
- •has a history of > 3 closures of pressure ulcers in the same site
- •has a history of a bleeding disorder
- •has severe fecal incontinence
研究组 & 干预措施
Fluid Immersion Simulation System (FIS)
Active Comparator
Pressure ulcer patients are assigned to Fluid Immersion Simulation System (Dolphin) after operative debridement and closure.
干预措施: Fluid Immersion Simulation System (Device)
Air Fluidized Bed System (AFB)
Active Comparator
Pressure ulcer patients are assigned to Air Fluidized Bed (Clinitron) after operative debridement and closure
干预措施: Air Fluidized Bed System (Device)
结局指标
主要结局
Percentage of Participants With Successful Closure of Wound at 2 Weeks After Surgery
时间窗: 2 weeks
Comparison of successful closure of wound at 2 weeks after surgery between treatment groups.
次要结局
- Differences in Quantitative Patient Survey Responses: Acceptability(2 weeks)
- Differences in Quantitative Nurse Survey Responses(2 weeks)
- Number of Participants With Complications(2 weeks)
研究者
Robert Galiano
Associate Professor of Surgery (Plastic Surgery) and Dermatology
Northwestern University
研究点 (1)
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