Cardiac Surgery, Infection, Soft Tissue, Self Management, Swabs, Wound Healing
Conditions
Keywords
swab, wound, self-swab, home swabbing, surgical, surgery, infection
Brief summary
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.
Interventions
PROCEDURESelf-swabbing of surgical wound
Participants will perform self-swabbing of their surgical wound under observation by a research practitioner via secure video call.
Sponsors
Guy's and St Thomas' NHS Foundation Trust
University of Nottingham
Liverpool Heart and Chest Hospital NHS Foundation Trust
Health Innovation East Midlands
Birmingham Community Healthcare NHS
University Hospitals Sussex NHS Foundation Trust
Centre for Healthcare Equipment and Technology Adoption
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who successfully perform self-swabbing at home | 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 | months 7-11 | assessed through participant interviews |
| Adherence to the swabbing protocol | 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 | months 7-11 | Adverse events during the swabbing process evaluated during observations conducted at the time of swabbing and during follow-up interviews |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant ratings on the acceptability of the swabbing instructions | Immediately after the self-swabbing process during participant interviews (months 7-11) | Acceptability of the swabbing instructions will be measured through participant interviews. |
| Participant ratings on the acceptability of the swabbing kit | Immediately after the self-swabbing process during participant interviews (months 7-11) | Acceptability of the swabbing kit will be measured through participant interviews |
| Transport Time taken for swabs to reach the laboratory | months 7-11 | Measured in hours, collected during laboratory processing |
| Number of usable swabs (viable for analysis) | months 7-11 | Measured during laboratory processing |
| Recruitment and retention rates | months 7-11 | To be measured continuously during the trial to inform the design of a larger trial |
| Patient demographics distribution | months 7-11 | To be measured continuously during the trial to inform the design of a larger trial |
| New swabbing at home pathway | months 7-11 | — |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORSunil Bhudia
Royal Brompton and Harefield Hospitals, part of Guy's and St Thomas' NHS Foundation Trust (GSTFT)
PRINCIPAL_INVESTIGATORIshtiaq Ahmed
University Hospitals Sussex NHS Foundation Trust
Outcome results
None listed