Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Average Time of Required Fistula-specific Dressing Changes - Inpatient
研究概览
简要总结
This study aims to assess the efficacy of a custom fitted device designed to isolate enteroatmospheric fistulas effluent independent of negative pressure wound therapy and to evaluate the effects on the device related to dressing changes, time required for dressing changes, management costs, and the ease of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Stable condition, as determined by attending physician
- •Has enteroatmospheric fistula (EAF) in the setting of open abdomen
- •EAF is determined to require surgical resolution
排除标准
- •Unstable condition, as determined by attending physician
- •Significant risk of complication
研究组 & 干预措施
Enteroatmospheric fistula (EAF) management solution
Participants will receive a custom fitted device designed to isolate EAF effluent independent of negative pressure wound therapy (NPWT) utilizing 3D printing technology to design a participant-matched device that more easily and effectively separates the participant's fistula and any emanated intestinal contents surrounding the wound.
干预措施: 3D printed EAF management device (Device)
结局指标
主要结局
Change in Average Time of Required Fistula-specific Dressing Changes - Inpatient
时间窗: Daily from admission to discharge, up to 1 year
The time required to change the wound dressings will be recorded.
Change in Outpatient Participant Mobility Assessment
时间窗: Weekly from until fistula resolves or study ends, up to 1 year
Mobility will be assessed by asking the participant to select the following statement that most accurately describes their mobility: a. completely immobile; b. unable to sit up supported for less than 10 minutes; c. able to sit supported for more than 10 minutes; d. able to sit unsupported, can lift arms; e. can stand up and pivot torso; or f. Can walk and move with minimal assistance required.
Change in Perceived Usefulness - Outpatient
时间窗: Weekly from discharge until fistula resolves or study ends, up to 1 year
Outpatient participants will be asked two questions about the perceived usefulness of the device. The questions use a 5-point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived usefulness.
Change in Perceived Usefulness - Inpatient
时间窗: Daily from admission to discharge, up to 1 year
Inpatient participants will be asked three questions about the perceived usefulness of the device. The questions use a 5-point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived usefulness.
Change in Perceived Ease of Use - Inpatient
时间窗: Daily from admission to discharge, up to 1 year
Inpatient participants will be asked four questions about the perceived ease of use of the device. The question uses a 5 point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived ease of use.
Change in Outpatient Participant Pain Rating
时间窗: Weekly from discharge until fistula resolves or study ends, up to 1 year
Participants will be asked to rate their pain on a scale of 1-10, where 10 indicates more pain.
Change in Number of Required Wound Dressing Changes - Inpatient
时间窗: Daily from admission to discharge, up to 1 year
The number of dressing changes will be tracked for inpatients on a daily bases.
Change in Perceived Ease of Use - Outpatient
时间窗: Weekly from discharge until fistula resolves or study ends, up to 1 year
Inpatient participants will be asked four questions about the perceived ease of use of the device. The question uses a 5 point Likert scale ranging from strongly disagree to strongly agree, where strongly agree indicates a higher perceived ease of use.
Change in Inpatient Participant Pain Rating
时间窗: Daily from admission to discharge, up to 1 year
Participants will be asked to rate their pain on a scale of 1-10, where 10 indicates more pain.
Change in Inpatient Participant Mobility Assessment
时间窗: Daily from admission to discharge, up to 1 year
Mobility will be assessed by asking the participant to select the following statement that most accurately describes their mobility: a. completely immobile; b. unable to sit up supported for less than 10 minutes; c. able to sit supported for more than 10 minutes; d. able to sit unsupported, can lift arms; e. can stand up and pivot torso; or f. can walk and move with minimal assistance required.
Change in Number of Required Wound Dressing Changes - Outpatient
时间窗: Daily from discharge until fistula resolves or study ends, up to 1 year
The number of dressing changes will be tracked for outpatients on a daily bases.
次要结局
- Length of Stay(Through duration of study, up to 1 year)
- Fistula Resolution Time(Through duration of study, up to 1 year)
- Complication Occurrences(Through duration of study, up to 1 year)
- Infection Rates(Through duration of study, up to 1 year)
- Number of Observed Leakages(Through duration of study, up to 1 year)
研究者
Andrew Bernard
Professor
University of Kentucky