Home self-swabbing for chest wounds after cardiac surgery
A Feasibility Study to Explore the Safety, Acceptability and Potential Cost Effectiveness of Self-swabbing at Home to Obtain Usable Surgical Wound Culture Swabs
This project will test whether adults who have had cardiac surgery can safely and easily take their own chest-wound swabs at home so labs can detect infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 2 sites (Brighton and 1 other locations) |
| Trial ID | NCT07200401 on ClinicalTrials.gov |
What this trial studies
This observational feasibility project will recruit adults with central chest wounds after cardiac surgery from two UK hospitals to see if they can self-collect wound swabs at home. Participants will receive a co-designed instruction pack and will be guided (including via video consultation) on how to take and return swabs for microbiological testing. The study will examine swab quality, record any safety concerns, and survey patients about acceptability and ease of use. It will also consider whether home self-swabbing could be a cost-effective approach to monitoring for surgical wound infections.
Who should consider this trial
Good fit: Adults (≥18) who had elective or urgent cardiac surgery via median sternotomy with a closed central chest wound, have been discharged to home or a care home, and can give informed consent and follow the swabbing instructions.
Not a fit: Patients with open or deep wounds, heavy or constant wound discharge, wounds covered by dressings at the time of consultation, those still in hospital, undergoing emergency/salvage surgery, or with significant immunodeficiency are unlikely to benefit from home self-swabbing under this protocol.
Why it matters
Potential benefit: If successful, home self-swabbing could help catch wound infections earlier and reduce the need for in-person clinic visits.
How similar studies have performed: Home self-swabbing and patient-collected samples have shown promise for other infection surveillance and screening uses, but applying this specifically to post-cardiac median sternotomy wounds is relatively new.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brighton and 1 other locations
- Royal Sussex County Hospital — Brighton, United Kingdom (Not_yet_recruiting)
- Harefield Hospital — Harefield, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sunil Bhudia — Royal Brompton and Harefield Hospitals, part of Guy's and St Thomas' NHS Foundation Trust (GSTFT)
- Study coordinator: Melissa Rochon
- Email: M.Rochon@rbht.nhs.uk
- Phone: +447545158766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.