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

G

Guy's and St Thomas' NHS Foundation Trust

Status

Enrolling

Conditions

Cardiac Surgery
Swabs
Wound Healing
Infection, Soft Tissue
Self Management

Treatments

Procedure: Self-swabbing of surgical wound

Study type

Interventional

Funder types

Other

Identifiers

NCT07200401
IRAS 356847

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Self-Swabbing Group
Experimental group
Description:
≥18 years old with median sternotomies (central wounds) after cardiac surgery will be drawn from two hospital sites
Treatment:
Procedure: Self-swabbing of surgical wound

Trial contacts and locations

2

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Central trial contact

Melissa Rochon; Judith Tanner

Data sourced from clinicaltrials.gov

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