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临床试验/NCT07471243
NCT07471243招募中不适用

Dressing-Related Experiences and Surgical Site Self-Care in Hip and Knee Replacement: an Observational Cohort Study (DRESS-X)

Bournemouth University3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年7月23日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
3
主要终点
The proportion of participants responding "yes" to each item of the ISWCAP checklist at 6-weeks post-surgery

研究概览

简要总结

The goal of this prospective observational cohort study is to investigate dressing-related experiences and surgical site self-care in patients who are undergoing a total hip or knee replacement. The main objectives of the study are:

  • To evaluate patient adherence to the ISWCAP self-care checklist after total hip or knee replacement within an ERAS pathway.
  • To explore patient-reported outcomes related to the performance and comfort of advanced dressings.
  • To assess the perceived adequacy and usefulness of post-discharge wound care education.
  • To identify the incidence and types of wound-related complications in the 12 weeks following surgery.

Participants will give informed consent before surgery and will start the study once the dressing has been applied following surgery. There will be follow up study visits at discharge, 7 days, 12 days, 6 weeks and 12 weeks post-surgery. Data relating to vital signs, medical history, surgery and medication will be taken from routine data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adults (18+) undergoing primary total hip or knee replacement
  • Enrolled in an ERAS protocol
  • Willing and able to provide informed consent

排除标准

  • Requiring revision replacement
  • Unable to provide informed consent (cognitive disorder such as dementia, psychiatric illness)
  • Unable to understand written English

结局指标

主要结局

The proportion of participants responding "yes" to each item of the ISWCAP checklist at 6-weeks post-surgery

时间窗: 6-weeks post surgery

次要结局

  • Bluebelle Wound Healing Questionnaire, completed at Visits 5 (12-days post-surgery) and 6 (6-weeks post-surgery)(12-days post-surgery and 6-weeks post-surgery)
  • Incidence and types of wound complications such as infection, dehiscence (as measured by the Sandy Grading System for surgical wound dehiscence classification), and blistering in the 12-weeks following surgery(From surgery until the 12-week follow-up appointment)
  • Dressing Comfort and Usability Survey completed at Visits 4 (7-days post-surgery) and 5 (12-days post-surgery)(7- and 12-days post-surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tom Wainwright

Professor of Orthopaedics

Bournemouth University

研究点 (3)

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