Scout Overlay-Trace-On-Thermal Feature in a Wound Clinic Setting: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Mode pixel value of the thermal wound surface
研究概览
简要总结
The purpose of this study is to test and evaluate how well a medical imaging device that takes both visual and thermal pictures of wounds or body surface areas of interest can help collect added information about the wounds or body surface areas of interest in a wound clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 18 or greater, of either gender and of any ethnic background
- •Able to tolerate position change(s) and turns for up to 10 minutes comfortably
- •Have an existing external wound or body surface area of interest:
- •External wound or body surface area of interest must be in separate body locations (ex: one on the right heel, one on the left heel, and the other on the sacrum)
- •Have qualifying external wound or body surface area of interest:
- •External wound or body surface area of interest that fits entirely within the field of view and does not wrap around a body edge
- •No device or treatment will obscure the external wound or body surface area of interest
排除标准
- •Neonatal and pediatric patients
- •Pregnant women
- •Cannot tolerate position changes for up to 10 minutes comfortably (per external wound site imaged)
- •On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy
- •Have a wound dressing or medical device which cannot or should not be removed as determined by site investigator
- •Have an external wound with excessive or heavy exudate that cannot be controlled during the imaging session. Excessive drainage can obscure external wound features.
- •If the patient has a complex external wound:
- •The external wound wraps around a body edge or otherwise cannot be imaged entirely within the visual field of view.
- •From visual assessment, the external wound edges are not definable and/or cannot be clearly distinguished from other conditions near external wound (E.g. breakdown or the deterioration of the surrounding body surfaces due to other conditions such as cancer or other types of ulcers makes determining the edge of the external wound impossible).
- •Have not provided signed informed consent
- •Non-English speaking
- •Subjects in isolation
结局指标
主要结局
Mode pixel value of the thermal wound surface
时间窗: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Mode pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits at the wound clinic for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Pixel gradient of the thermal unaffected area of body surface selected
时间窗: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Pixel gradient of the the thermal unaffected area of body surface selected will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Adjacent tissue trace's surface % relative temperature above, below, or equal to the unaffected reference area's temperature
时间窗: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Adjacent tissue trace's surface's % relative temperature above, below, or equal to the unaffected reference area's relative temperature, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Pixel gradient of the thermal wound surface
时间窗: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Pixel gradient of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Mean pixel value of the thermal wound surface
时间窗: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Mean pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Highest pixel value of the thermal wound surface
时间窗: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Highest pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Lowest pixel value of the thermal wound surface
时间窗: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Lowest pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Comparison of adjacent tissue trace around the wound bed's surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit).
时间窗: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Comparison of adjacent tissue trace around the wound bed's surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit), with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Comparison of wound surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit).
时间窗: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Comparison of wound surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit), with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Wound surface's % relative temperature above, below, or equal to the unaffected reference area's temperature
时间窗: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Wound surface's % relative temperature above, below, or equal to the unaffected reference area's relative temperature, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
次要结局
未报告次要终点