A Feasibility Study to Explore the Safety, Acceptability and Potential Cost Effectiveness of Self-swabbing at Home to Obtain Usable Surgical Wound Culture Swabs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Proportion of participants who successfully perform self-swabbing at home
研究概览
简要总结
The goal of this observational feasibility study is to learn if patients can safely, acceptably, and effectively collect their own wound swabs at home to detect clinically significant organisms in adults aged 18 and over who have had cardiac surgery via median sternotomy (central chest wound). Participants will be recruited from two sites: Harefield Hospital (Guy's and St Thomas' NHS Foundation Trust, London) and the Royal Sussex County Hospital (University Hospitals Sussex, Brighton).
The main questions it aims to answer are:
- Can home-based patient self-swabbing of surgical wounds provide swabs of sufficient quality for microbiological testing?
- Is self-swabbing at home safe and acceptable to patients following cardiac surgery?
- Could this approach be a cost-effective way to monitor for surgical wound infections?
Participants will:
- Receive a co-designed self-swabbing instruction pack, created in collaboration with a patient and public working group and clinical experts.
- Be observed via Microsoft Teams by a research practitioner while self-swabbing (or having their carer do so) to assess usability and adherence to instructions.
- Participate in a brief interview to share their experiences and feedback on the instructions and swabbing process.
- Send completed swabs to the hospital laboratory for analysis to determine the usability and timeliness of the samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Feasibility Study
- •Cardiac surgery ≥18 years old patients with a central chest wound, where the wound is a closed wound - assessed by the research nurse
- •Patients having elective or urgent surgery
- •Patients who have been discharged home or to a care home
- •Willing and able to provide written informed consent prior to participation in the clinical investigation.
- •Willing and able to comply with all study related procedures, with or without digital resource/internet access.
排除标准
- •Feasibility Study
- •Cardiac surgery patients with open wounds extending beyond skin level, or where deep tissue, organs or implants are visible, wounds with constant or heavy discharge of fluid, wounds leaking pus at the time of the video consultation.
- •Patients having emergency or salvage surgery
- •Patients still in hospital
- •Patients with a dressing covering their wound at the time of the video consultation.
- •Congenital or acquired immunodeficiency, bone marrow disease, diabetes, autoimmune conditions requiring immunosuppressive treatment, any immunosuppressive medication at the time of consent or within the last 4 weeks before consent.
- •Undergoing active cancer treatment at time of consent/ or planning to start cancer treatment within the study period or completed cancer treatment within the last 4 weeks of the study commencing.
- •Patients who lack capacity to consent
研究组 & 干预措施
Self-Swabbing Group
≥18 years old with median sternotomies (central wounds) after cardiac surgery will be drawn from two hospital sites
干预措施: Self-swabbing of surgical wound (Procedure)
结局指标
主要结局
Proportion of participants who successfully perform self-swabbing at home
时间窗: months 7-11
The proportion of participants who successfully perform self-swabbing at home approximately two weeks post-discharge, with the swab sample delivered to the laboratory within 24 hours and deemed viable for laboratory analysis.
Proportion of participants who successfully perform self-swabbing at home
时间窗: months 7-11
The proportion of participants who successfully perform self-swabbing at home approximately two weeks post-discharge, with the swab sample delivered to the laboratory within 24 hours and deemed viable for laboratory analysis.
Participant ratings on the acceptability of the swabbing process
时间窗: months 7-11
assessed through participant interviews
Adherence to the swabbing protocol
时间窗: months 7-11
Number of participants who adhere to the swabbing protocol. Evaluated during observations conducted at the time of swabbing and during follow-up interview
Adverse events during the swabbing process
时间窗: months 7-11
Adverse events during the swabbing process evaluated during observations conducted at the time of swabbing and during follow-up interviews
次要结局
- Participant ratings on the acceptability of the swabbing instructions(Immediately after the self-swabbing process during participant interviews (months 7-11))
- Participant ratings on the acceptability of the swabbing kit(Immediately after the self-swabbing process during participant interviews (months 7-11))
- Transport Time taken for swabs to reach the laboratory(months 7-11)
- Number of usable swabs (viable for analysis)(months 7-11)
- Recruitment and retention rates(months 7-11)
- Patient demographics distribution(months 7-11)
- Participant ratings on the acceptability of the swabbing instructions(Immediately after the self-swabbing process during participant interviews (months 7-11))
- Participant ratings on the acceptability of the swabbing kit(Immediately after the self-swabbing process during participant interviews (months 7-11))
- Transport Time taken for swabs to reach the laboratory(months 7-11)
- Number of usable swabs (viable for analysis)(months 7-11)
- Recruitment and retention rates(months 7-11)
- Patient demographics distribution(months 7-11)
- New swabbing at home pathway(months 7-11)