Exploring if Patients Can Safely and Easily Swab Their Own Surgical Wounds at Home

Not Applicable

Not yet recruiting

• Conditions: Cardiac Surgery; Infection, Soft Tissue; Wound Healing; Swabs; Self Management

• Registration Number: NCT07200401
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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 nurse 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-12
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study Start: 2025-10-01
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2026-04
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Participant ratings on the acceptability of the swabbing process	Immediately after the self-swabbing process during participant interviews (months 7-11)	Acceptability of the swabbing process will be measured using Likert scales (quantitative) and thematic analysis from participant interviews (qualitative).
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 using using Likert scales (quantitative) and thematic analysis from participant interviews (qualitative).
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 using using Likert scales (quantitative) and thematic analysis from participant interviews (qualitative).
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 interviews.
Adverse events during the swabbing process	months 7-11	Evaluated during observations conducted at the time of swabbing and during follow-up 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
Insights from clinical stakeholder interviews	months 7-9	Collected from staff stakeholder interviews measured using thematic analysis
Recruitment and retention rates	months 7-11	To be measured continuously during the trial to inform the design of a larger trial
Swabbing adherence 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

Trial Locations

Locations (2)

Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom

Harefield Hospital; 🇬🇧 Harefield, United Kingdom