Tracking Wound Infection With Smartphone Technology (TWIST)
Can a Smartphone-delivered Tool Facilitate the Assessment of Surgical Site Infection, and Result in Earlier Treatment? A Randomized-controlled Trial in Emergency Surgery Patients.
研究概览
详细说明
Surgical site infection (SSI) is defined by the Centre for Disease Control and Prevention (CDC) as an infection in the skin and soft tissues of a surgical wound, within 30 days of the operation. It is a common problem, and complicates 2-10% of general surgery operations. The majority of cases are diagnosed outside of hospital and can be treated with oral antibiotics.
Interest in the use of technology in medicine is increasing, with the potential that more advanced technology will help facilitate communication between clinicians and patients, aid in the assessment of patients, and improve clinical decision making. Over two-thirds of people now own smartphones, and regularly use them to access the internet. The investigators wish to use a smartphone delivered questionnaire to help assess SSI and see if this improves access to care and time to treatment.
The investigators will be recruiting emergency surgery patients with smartphones at the Royal Infirmary and Western General Hospitals in Edinburgh.
Participants will be divided into two groups. One group will receive the wound assessment tool, if they are concerned about their wound, they can use the tool to answer a series of questions. If their answers suggest SSI, a clinician will contact them to advise further assessment and treatment. The participants will also be asked to respond to the tool three times during the trial (to collect responses from those without symptoms), and upload photos of their wounds to a secure database.
The second group of participants will receive normal post-operative care.
After 30 days, participants will have a follow-up consultation, to determine if they have had a wound infection (this can be via telephone or face-to-face, according to participant preference). They will also answer questions about their experience of the study, and use of services.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Ewen Harrison, BM CHB
- 电话号码:0131 242 3616
- 邮箱:ewen.harrison@ed.ac.uk
学习地点
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Edinburgh、英国、EH4 2XU
- 招聘中
- Western General Hospital
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接触:
- Mark Potter, MBCHB
- 邮箱:mark.potter@nhslothian.scot.nhs.uk
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Edinburgh、英国、EH16 4SA
- 招聘中
- Royal Infirmary Edinburgh
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接触:
- Ewen M Harrison, BMBCH
- 电话号码:0131 242 3616
- 邮箱:ewen.harrison@ed.ac.uk
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Emergency Abdominal Surgery Patients
- Smartphone Owners
- Able to give valid consent
Exclusion Criteria:
- Significant visual impairment
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Intervention Arm
Wound assessment tool - delivered via a smartphone. A link will be sent to participants on discharge, which can be accessed at any point should they have concerns about their wound. They will also be sent the tool at 3 additional time-points. |
A set of questions relating to the symptoms of wound infection
|
无干预:Control Arm
Normal Post-operative Care
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Time from surgery to treatment for surgical site infection
大体时间:Outcome assessed at 30 day follow-up
|
Measured in days from surgery to commencing antibiotic treatment
|
Outcome assessed at 30 day follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Service Usage
大体时间:Assessed at 30 day follow-up
|
Number of attendances at General Practice (GP) and Accident and Emergency (A&E).
|
Assessed at 30 day follow-up
|
Access to Services
大体时间:Assessed at 30 day follow-up
|
How long in days between experiencing first symptom and being reviewed by A&E, GP or surgical team
|
Assessed at 30 day follow-up
|
合作者和调查者
调查人员
- 首席研究员:Ewen Harrison, BM CHB、University of Edinburgh
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Wound Assessment Tool的临床试验
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Integra LifeSciences CorporationSt Vincent's Hospital完全的
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Brigham and Women's HospitalCenter for Integration of Medicine & Innovative Technology; Fogarty International Clinical Research...完全的