Cardiac SurgeryTREASURENCT07200401
Exploring if Patients Can Safely and Easily Swab Their Own Surgical Wounds at Home
A study testing Self-swabbing of surgical wound in people with Cardiac Surgery and Infection, Soft Tissue, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Infection, Soft Tissue, Wound Healing
- What is being tested?
- Self-swabbing of surgical wound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Jan 2026to 2 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
Harefield Hospital
Harefield, UB9 6JH
About this study
Official 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
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:
Read more
- 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.
- Conditions
- Cardiac Surgery, Infection, Soft Tissue, Wound Healing, Swabs, Self Management
- Being tested
- Self-swabbing of surgical wound
- Keywords
- swab, wound, self-swab, home swabbing, surgical, surgery, infection
- Medical subject headings
- Soft Tissue Infections, Wounds and Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-swabbing of surgical woundProcedure or surgery
Participants will perform self-swabbing of their surgical wound under observation by a research practitioner via secure video call.
| Study group | Role | What they receive |
|---|---|---|
| Self-Swabbing Group | Experimental | ≥18 years old with median sternotomies (central wounds) after cardiac surgery will be drawn from two hospital sites Receives: Procedure: Self-swabbing of surgical wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who successfully perform self-swabbing at home
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.
Measured: months 7-11
Participant ratings on the acceptability of the swabbing process
assessed through participant interviews
Measured: months 7-11
Adherence to the swabbing protocol
Number of participants who adhere to the swabbing protocol. Evaluated during observations conducted at the time of swabbing and during follow-up interview
Measured: months 7-11
Adverse events during the swabbing process
Adverse events during the swabbing process evaluated during observations conducted at the time of swabbing and during follow-up interviews
Measured: months 7-11
Secondary outcomes (7)
Participant ratings on the acceptability of the swabbing instructions
Acceptability of the swabbing instructions will be measured through participant interviews.
Measured: Immediately after the self-swabbing process during participant interviews (months 7-11)
Participant ratings on the acceptability of the swabbing kit
Acceptability of the swabbing kit will be measured through participant interviews
Measured: Immediately after the self-swabbing process during participant interviews (months 7-11)
Transport Time taken for swabs to reach the laboratory
Measured in hours, collected during laboratory processing
Measured: months 7-11
Number of usable swabs (viable for analysis)
Measured during laboratory processing
Measured: months 7-11
Recruitment and retention rates
To be measured continuously during the trial to inform the design of a larger trial
Measured: months 7-11
Patient demographics distribution
To be measured continuously during the trial to inform the design of a larger trial
Measured: months 7-11
New swabbing at home pathway
Measured: months 7-11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start6 Jan 2026
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Sunil Bhudia, Principal investigator, Royal Brompton and Harefield Hospitals, part of Guy's and St Thomas' NHS Foundation Trust (GSTFT)Ishtiaq Ahmed, Principal investigator, University Hospitals Sussex NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200401
- Sponsor's protocol ID
- IRAS 356847
- Acronym
- TREASURE
- Status last verified
- Sep 2025
- First submitted
- 12 Aug 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On completion of the study, anonymised quantitative data from the interviews and anonymised themed analysis of qualitative data from the interviews will be stored in and made publicly available through the University of Nottingham data repository (https://rdmc.nottingham.ac.uk/)
Publications
Census - Office for National Statistics (ons.gov.uk) Accessed 07/07/2024
Tanner J, Brierley Jones L, Westwood N, Rochon M, Wloch C, Rogers LJ, Vaja R, Dearling J, Wilson K, Harrington P, Brown CS, Murphy G. Exploratory study of patients' and carers' preferences for postdischarge surgical wound monitoring using survey and interviews. BMJ Open. 2025 Jan 25;15(1):e087320. doi: 10.1136/bmjopen-2024-087320.
PubMed 39863412M. Rochon (2023) Surgical Site Infection surveillance: Time for a new agenda? Society of Tissue Viability: Advances in surgical wound management and reducing surgical site infection.(SSI) https://societyoftissueviability.org/whats-on/advances-in-surgical-wound-management-and-reducingsurgical-site-infection-ssi/
Atchison C, Pristera P, Cooper E, Papageorgiou V, Redd R, Piggin M, Flower B, Fontana G, Satkunarajah S, Ashrafian H, Lawrence-Jones A, Naar L, Chigwende J, Gibbard S, Riley S, Darzi A, Elliott P, Ashby D, Barclay W, Cooke GS, Ward H. Usability and Acceptability of Home-based Self-testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibodies for Population Surveillance. Clin Infect Dis. 2021 May 4;72(9):e384-e393. doi: 10.1093/cid/ciaa1178.
PubMed 32785665Rochon M, Jawarchan A, Ingusan S, Cariaga K and Morais C. 'Project ID007672: Clinical audit of patient-reported antibiotics for wound problems following surgery and review of alternative strategies'. 25/02/2023. Unpublished.
NHS England. Delivering a net zero National Health Service. Greener NHS " Delivering a 'Net Zero' National Health Service (england.nhs.uk) Accessed 27/02/2024
NHS England. The NHS Long Term Plan. NHS England " The NHS Long Term Plan. Accessed 27/02/2024
Royal College of General Practitioners. RCGP response to the Antimicrobial resistance national action plan: Call for evidence. Accessed 29/02/2024
Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022 Feb 12;399(10325):629-655. doi: 10.1016/S0140-6736(21)02724-0. Epub 2022 Jan 19.
PubMed 35065702GIRFT 2019 GIRFT National Survey April 2019 Layout 1 (gettingitrightfirsttime.co.uk)
Tanner J, Padley W, Davey S, Murphy K, Brown B. Patient narratives of surgical site infection: implications for practice. J Hosp Infect. 2013 Jan;83(1):41-5. doi: 10.1016/j.jhin.2012.07.025. Epub 2012 Oct 22.
PubMed 23088921Cardiothoracic Interdisciplinary Research Network. Electronic address: CIRNetwork@outlook.com; National Cardiac Benchmarking Collaborative; Public Health England; Cardiothoracic Interdisciplinary Research Network. National survey of variations in practice in the prevention of surgical site infections in adult cardiac surgery, United Kingdom and Republic of Ireland. J Hosp Infect. 2020 Dec;106(4):812-819. doi: 10.1016/j.jhin.2020.09.016. Epub 2020 Sep 19.
PubMed 32956785UKHSA Surveillance of surgical site infections in NHS hospitals in England: April 2022 to March 2023. London UKHSA 2023
Rochon M, Cariaga K, Sa F, et al. 2023 The unrecognised burden of post-discharge antibiotic consumption for surgical wounds. Abstract. The 37TH EACTS Annual Meeting 4- 7 October 2023, Vienna, Austria. Programme (y-congress.com)
Research reveals levels of inappropriate prescriptions in England - GOV.UK (www.gov.uk)
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07200401
- Acronym / sponsor ID
- TREASURE / IRAS 356847
- Conditions
- Cardiac Surgery, Infection, Soft Tissue, Wound Healing, Swabs, Self Management
- Keywords
- swab, wound, self-swab, home swabbing, surgical, surgery, infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- 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 start
- 6 Jan 2026 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-Swabbing Group | Experimental | Procedure: Self-swabbing of surgical wound≥18 years old with median sternotomies (central wounds) after cardiac surgery will be drawn from two hospital sites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Feasibility Study
Key exclusion criteria (8 listed)
- Feasibility Study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-swabbing of surgical woundParticipants will perform self-swabbing of their surgical wound under observation by a research practitioner via secure video call. | Procedure or surgery | Self-Swabbing Group |
Primary outcome
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.
Participant ratings on the acceptability of the swabbing process
Time frame: months 7-11
assessed through participant interviews
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
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
7 secondary outcomes
Participant ratings on the acceptability of the swabbing instructions
Time frame: Immediately after the self-swabbing process during participant interviews (months 7-11)
Participant ratings on the acceptability of the swabbing kit
Time frame: Immediately after the self-swabbing process during participant interviews (months 7-11)
Transport Time taken for swabs to reach the laboratory
Time frame: months 7-11
Number of usable swabs (viable for analysis)
Time frame: months 7-11
Recruitment and retention rates
Time frame: months 7-11
Patient demographics distribution
Time frame: months 7-11
New swabbing at home pathway
Time frame: months 7-11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- BackgroundCensus - Office for National Statistics (ons.gov.uk) Accessed 07/07/2024
- Background: PubMed 39863412Tanner J, Brierley Jones L, Westwood N, Rochon M, Wloch C, Rogers LJ, Vaja R, Dearling J, Wilson K, Harrington P, Brown CS, Murphy G. Exploratory study of patients' and carers' preferences for postdischarge surgical wound monitoring using survey and interviews. BMJ Open. 2025 Jan 25;15(1):e087320. doi: 10.1136/bmjopen-2024-087320.
- BackgroundM. Rochon (2023) Surgical Site Infection surveillance: Time for a new agenda? Society of Tissue Viability: Advances in surgical wound management and reducing surgical site infection.(SSI) https://societyoftissueviability.org/whats-on/advances-in-surgical-wound-management-and-reducingsurgical-site-infection-ssi/
- Background: PubMed 32785665Atchison C, Pristera P, Cooper E, Papageorgiou V, Redd R, Piggin M, Flower B, Fontana G, Satkunarajah S, Ashrafian H, Lawrence-Jones A, Naar L, Chigwende J, Gibbard S, Riley S, Darzi A, Elliott P, Ashby D, Barclay W, Cooke GS, Ward H. Usability and Acceptability of Home-based Self-testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibodies for Population Surveillance. Clin Infect Dis. 2021 May 4;72(9):e384-e393. doi: 10.1093/cid/ciaa1178.
- BackgroundRochon M, Jawarchan A, Ingusan S, Cariaga K and Morais C. 'Project ID007672: Clinical audit of patient-reported antibiotics for wound problems following surgery and review of alternative strategies'. 25/02/2023. Unpublished.
- BackgroundNHS England. Delivering a net zero National Health Service. Greener NHS " Delivering a 'Net Zero' National Health Service (england.nhs.uk) Accessed 27/02/2024
- BackgroundNHS England. The NHS Long Term Plan. NHS England " The NHS Long Term Plan. Accessed 27/02/2024
- BackgroundRoyal College of General Practitioners. RCGP response to the Antimicrobial resistance national action plan: Call for evidence. Accessed 29/02/2024
- Background: PubMed 35065702Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022 Feb 12;399(10325):629-655. doi: 10.1016/S0140-6736(21)02724-0. Epub 2022 Jan 19.
- BackgroundGIRFT 2019 GIRFT National Survey April 2019 Layout 1 (gettingitrightfirsttime.co.uk)
- Background: PubMed 23088921Tanner J, Padley W, Davey S, Murphy K, Brown B. Patient narratives of surgical site infection: implications for practice. J Hosp Infect. 2013 Jan;83(1):41-5. doi: 10.1016/j.jhin.2012.07.025. Epub 2012 Oct 22.
- Background: PubMed 32956785Cardiothoracic Interdisciplinary Research Network. Electronic address: CIRNetwork@outlook.com; National Cardiac Benchmarking Collaborative; Public Health England; Cardiothoracic Interdisciplinary Research Network. National survey of variations in practice in the prevention of surgical site infections in adult cardiac surgery, United Kingdom and Republic of Ireland. J Hosp Infect. 2020 Dec;106(4):812-819. doi: 10.1016/j.jhin.2020.09.016. Epub 2020 Sep 19.
- Individual participant dataSharing planned: Yes. On completion of the study, anonymised quantitative data from the interviews and anonymised themed analysis of qualitative data from the interviews will be stored in and made publicly available through the University of Nottingham data repository (https://rdmc.nottingham.ac.uk/)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Bhudia principal investigator
Royal Brompton and Harefield Hospitals, part of Guy's and St Thomas' NHS Foundation Trust (GSTFT)
Ishtiaq Ahmed principal investigator
University Hospitals Sussex NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-swabbing of surgical wound in people with Cardiac Surgery and Infection, Soft Tissue, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who successfully perform self-swabbing at home (time frame: months 7-11). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07200401, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.