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Completed

NCT Number: NCT07200401

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

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.

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Key information

Conditions

Cardiac Surgery Infection, Soft Tissue Infections Self Management Soft Tissue Infections Swabs Wound Healing Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Sussex County Hospital, Brighton, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-swabbing of surgical wound

Procedure

Participants will perform self-swabbing of their surgical wound under observation by a research practitioner via secure video call.

Primary outcomes

  1. Proportion of participants who successfully perform self-swabbing at home

    Time frame: 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.

  2. Participant ratings on the acceptability of the swabbing process

    Time frame: months 7-11

    assessed through participant interviews

  3. Adherence to the swabbing protocol

    Time frame: 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

  4. Adverse events during the swabbing process

    Time frame: months 7-11

    Adverse events during the swabbing process evaluated during observations conducted at the time of swabbing and during follow-up interviews

Secondary outcomes

  1. Participant ratings on the acceptability of the swabbing instructions

    Time frame: Immediately after the self-swabbing process during participant interviews (months 7-11)

    Acceptability of the swabbing instructions will be measured through participant interviews.

  2. Participant ratings on the acceptability of the swabbing kit

    Time frame: Immediately after the self-swabbing process during participant interviews (months 7-11)

    Acceptability of the swabbing kit will be measured through participant interviews

  3. Transport Time taken for swabs to reach the laboratory

    Time frame: months 7-11

    Measured in hours, collected during laboratory processing

  4. Number of usable swabs (viable for analysis)

    Time frame: months 7-11

    Measured during laboratory processing

  5. Recruitment and retention rates

    Time frame: months 7-11

    To be measured continuously during the trial to inform the design of a larger trial

  6. Patient demographics distribution

    Time frame: months 7-11

    To be measured continuously during the trial to inform the design of a larger trial

  7. New swabbing at home pathway

    Time frame: months 7-11

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • Birmingham Community Healthcare NHS
  • Centre for Healthcare Equipment and Technology Adoption
  • Health Innovation East Midlands
  • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • University Hospitals Sussex NHS Foundation Trust
  • University of Nottingham

Registry information

Official study title

A Feasibility Study to Explore the Safety, Acceptability and Potential Cost Effectiveness of Self-swabbing at Home to Obtain Usable Surgical Wound Culture Swabs

Acronym: TREASURE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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