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临床试验/NCT03355599
NCT03355599已完成不适用

Investigating the Benefits of a 3D Camera for Recording Healing Wound Dimensions

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年7月10日最近更新:
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
30
试验地点
2
主要终点
comparative consistency of the image

研究概览

简要总结

The study will explore whether a 3D camera data can provide a more accurate baseline measurement (compared to 2D images with manual measurement) to support better clinical decision making in referrals to tissue viability.

详细描述

Chronic and non-healing wounds are a significant problem to manage in community and represent a significant workload in community nursing. The current management for non-healing wounds includes referral to the tissue viability service, using a 2 D photographic image with assessment information. This study will pilot the use of a 3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention. The introduction of 3 D measurement and monitoring of wounds will be compared with usual care. With a target recruitment of 30 patients via tissue viability, the pilot will report on the feasibility of using this outcome measure and the effectiveness of monitoring on wound closure or improvement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must have a non-healing wound and be over 18 years of age the criteria for non-healing wounds is as per 5.1 on the community nursing referral criteria when considering referral of patients to tissue viability:
  • 'would expect that the wounds are deteriorating, chronic, non-healing or static or there are problems with the dressing regime'
  • Patients must be willing to provide written informed consent
  • Patients must have a registered Sheffield General Practitioner and be referred to tissue viability for a static or deteriorating wound

排除标准

  • Patients with circumferential leg ulcers
  • Patients with deep narrow sinus where the opening is less than 10mm
  • Wounds on the face where the image would include the eyes or distinguishing features
  • Patients unable to provide written informed consent.

研究组 & 干预措施

3d camera

Other

3d camera

干预措施: 3d camera (Other)

结局指标

主要结局

comparative consistency of the image

时间窗: 1 week

comparative reliability and consistency of the image between 2d and 3d images

comparative consistency of the measurement

时间窗: 1 week

comparative reliability and consistency of the measurements between 2d and 3d images

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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