Utilizing Visual and Thermal Images for the Measuring and Monitoring of External Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter
研究概览
简要总结
The purpose of this study is to test wounds found on the outside of the body surface with an investigational medical imaging device that collects visual pictures and thermal digital pictures of the wound site. The investigational device has not been approved by the Food and Drug Administration (FDA).
The medical imaging device is non-contacting and is non-radiating (delivers no energy to the body). It passively collects pictures (typical digital color photographs)and thermal pictures (black and white digital photographs of heat at the body surface.)
详细描述
This prospective study utilizes the WoundVision Wound Measuring and Monitoring System (WMMS) to study external wounds, which can currently be measured for length by width using a ruler. WMMS operates by taking simultaneous visual and thermal images of the external wound site and the associated body surface. These images are evaluated by utilizing the WMMS ImageReview measuring and monitoring software. WMMS ImageReview software allows for LxW (length by width) and surface area (cm squared),as well as perimeter (cm) external wound measurements of the visual image. WMMS ImageReview software also allows for the display of thermal intensity variation data for the associated body surface of the corresponding thermal image.
This study is primarily designed to utilize the Coefficients of Individual Agreement (CIA)as a means of establishing the equivalence of area measurements utilizing the WMMS ImageReview software LxW technique and the current "gold standard" LxW manual ruler technique.
A secondary objective measures the thermal intensity variation data of the external wound bed by overlaying the corresponding "Visual External Wound Trace"from the visual image onto the thermal wound bed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 changes and turns for up to 10 minutes comfortably
- •Have an existing external wound that is currently measured for length and width using a ruler
- •The protocol will allow imaging up to 3 external wounds per subject
- •The 3 external wounds 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 sites:
- •External wounds whose external wound site fits entirely within the field of view and do not wrap around a body edge.
- •No device or treatment will obscure the external wound site
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)
- •Cannot be positioned so images can be taken at approximately 90 degrees perpendicular and 18 inches away from the external wound site
- •On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy
- •Have external 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
- •Have complex external wound site(s):
- •The external wound wraps around a body edge or otherwise cannot be imaged entirely within the visual field of view
- •From visual assessment the existing external wound cannot be clearly distinguished from other conditions at the external wound site (e.g. break down or the deterioration of the surrounding body surfaces due to other conditions such as cancer or other types of wounds makes determining the edge of the external wound impossible)
- •Have not provided signed informed consent
- •Non-English speaking
研究组 & 干预措施
External wounds measured for length by width using a ruler
This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.
干预措施: "gold standard" LxW manual ruler measurement technique (Device)
External wounds measured for length by width using a ruler
This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.
干预措施: WMMS ImageReview software's LxW measurement technique (Device)
External wounds measured for length by width using a ruler
This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.
干预措施: WMMS ImageReview software's Visual External Wound Trace (Device)
External wounds measured for length by width using a ruler
This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.
干预措施: WMMS ImageReview software's External Wound Trace Overlay (Device)
结局指标
主要结局
Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter
时间窗: 90 Days
Establish within and between reader agreement of the Scout Length by Width, Scout trace area, and Scout trace perimeter.
次要结局
未报告次要终点