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

NCT ID: NCT07200401

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-06

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Surgery Infection, Soft Tissue Wound Healing Swabs Self Management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Self-Swabbing Group

≥18 years old with median sternotomies (central wounds) after cardiac surgery will be drawn from two hospital sites

Group Type EXPERIMENTAL

Self-swabbing of surgical wound

Intervention Type PROCEDURE

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

Interventions

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Self-swabbing of surgical wound

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nottingham

OTHER

Sponsor Role collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

Health Innovation East Midlands

UNKNOWN

Sponsor Role collaborator

Birmingham Community Healthcare NHS

OTHER_GOV

Sponsor Role collaborator

University Hospitals Sussex NHS Foundation

UNKNOWN

Sponsor Role collaborator

Centre for Healthcare Equipment and Technology Adoption

UNKNOWN

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sunil Bhudia

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton and Harefield Hospitals, part of Guy's and St Thomas' NHS Foundation Trust (GSTFT)

Ishtiaq Ahmed

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Sussex NHS Foundation Trust

Locations

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Royal Sussex County Hospital

Brighton, , United Kingdom

Site Status NOT_YET_RECRUITING

Harefield Hospital

Harefield, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Melissa Rochon

Role: CONTACT

+447545158766

Judith Tanner

Role: CONTACT

+441159515151

Facility Contacts

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Ishtiaq Ahmed

Role: primary

+447976432932

Sunil Bhudia

Role: primary

+447946185817

References

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Census - Office for National Statistics (ons.gov.uk) Accessed 07/07/2024

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 39863412 (View on PubMed)

M. 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/

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 32785665 (View on PubMed)

Rochon 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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

NHS England. The NHS Long Term Plan. NHS England " The NHS Long Term Plan. Accessed 27/02/2024

Reference Type BACKGROUND

Royal College of General Practitioners. RCGP response to the Antimicrobial resistance national action plan: Call for evidence. Accessed 29/02/2024

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 35065702 (View on PubMed)

GIRFT 2019 GIRFT National Survey April 2019 Layout 1 (gettingitrightfirsttime.co.uk)

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 23088921 (View on PubMed)

Cardiothoracic Interdisciplinary Research Network. Electronic address: [email protected]; 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.

Reference Type BACKGROUND
PMID: 32956785 (View on PubMed)

UKHSA Surveillance of surgical site infections in NHS hospitals in England: April 2022 to March 2023. London UKHSA 2023

Reference Type BACKGROUND

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)

Reference Type BACKGROUND

Research reveals levels of inappropriate prescriptions in England - GOV.UK (www.gov.uk)

Reference Type BACKGROUND

Woelber E, Schrick EJ, Gessner BD, Evans HL. Proportion of Surgical Site Infections Occurring after Hospital Discharge: A Systematic Review. Surg Infect (Larchmt). 2016 Oct;17(5):510-9. doi: 10.1089/sur.2015.241. Epub 2016 Jul 27.

Reference Type BACKGROUND
PMID: 27463235 (View on PubMed)

Wounds UK Prevention 2023 Identification and Management of Surgical Wound Dehiscence (SWD) SN23_CD_SWD_WUK-web.pdf (wounds-uk.com) Accessed 08/07/2024

Reference Type BACKGROUND

Han SM, Greenfield G, Majeed A, Hayhoe B. Impact of Remote Consultations on Antibiotic Prescribing in Primary Health Care: Systematic Review. J Med Internet Res. 2020 Nov 9;22(11):e23482. doi: 10.2196/23482.

Reference Type BACKGROUND
PMID: 33031045 (View on PubMed)

Other Identifiers

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IRAS 356847

Identifier Type: -

Identifier Source: org_study_id

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