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| Name | Class |
|---|---|
| University of Nottingham | OTHER |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | OTHER |
| Health Innovation East Midlands | UNKNOWN |
| Birmingham Community Healthcare NHS |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Swabbing Group | Experimental | ≥18 years old with median sternotomies (central wounds) after cardiac surgery will be drawn from two hospital sites |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | months 7-11 |
| Participant ratings on the acceptability of the swabbing process | assessed through participant interviews | 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 | 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 | months 7-11 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant ratings on the acceptability of the swabbing instructions | Acceptability of the swabbing instructions will be measured through participant interviews. | Immediately after the self-swabbing process during participant interviews (months 7-11) |
| Participant ratings on the acceptability of the swabbing kit |
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Inclusion Criteria:
Feasibility Study
Exclusion Criteria:
Feasibility Study
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Bhudia | Royal Brompton and Harefield Hospitals, part of Guy's and St Thomas' NHS Foundation Trust (GSTFT) | Principal Investigator |
| Ishtiaq Ahmed | University Hospitals Sussex NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Sussex County Hospital | Brighton | BN2 5BE | United Kingdom | |||
| Harefield Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Census - Office for National Statistics (ons.gov.uk) Accessed 07/07/2024 | ||
| 39863412 | 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. | |
| Background | 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/ | ||
| 32785665 |
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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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| ID | Term |
|---|---|
| D018461 | Soft Tissue Infections |
| D014947 | Wounds and Injuries |
| D007239 | Infections |
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| OTHER_GOV |
| University Hospitals Sussex NHS Foundation Trust | OTHER_GOV |
| Centre for Healthcare Equipment and Technology Adoption | UNKNOWN |
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Acceptability of the swabbing kit will be measured through participant interviews |
| 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 | months 7-11 |
| Number of usable swabs (viable for analysis) | Measured during laboratory processing | months 7-11 |
| Recruitment and retention rates | To be measured continuously during the trial to inform the design of a larger trial | months 7-11 |
| Patient demographics distribution | To be measured continuously during the trial to inform the design of a larger trial | months 7-11 |
| New swabbing at home pathway | months 7-11 |
| Harefield |
| UB9 6JH |
| United Kingdom |
| 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. |
| Background | 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. |
| 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 |
| Background | NHS England. The NHS Long Term Plan. NHS England " The NHS Long Term Plan. Accessed 27/02/2024 |
| Background | Royal College of General Practitioners. RCGP response to the Antimicrobial resistance national action plan: Call for evidence. Accessed 29/02/2024 |
| 35065702 | 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. |
| Background | GIRFT 2019 GIRFT National Survey April 2019 Layout 1 (gettingitrightfirsttime.co.uk) |
| 23088921 | 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. |
| 32956785 | Background | Cardiothoracic 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. |
| Background | UKHSA Surveillance of surgical site infections in NHS hospitals in England: April 2022 to March 2023. London UKHSA 2023 |
| 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) |
| Background | Research reveals levels of inappropriate prescriptions in England - GOV.UK (www.gov.uk) |
| 27463235 | 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. |
| Background | 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 |
| 33031045 | 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. |
| 41667168 | Derived | Rochon M, Tanner J, Cariaga K, Harris R, Wilson K, Newby C, Kariwo K, Sowole L, Bolton SJ, Bouttell J, Ahmed I. Is home-based self-swabbing feasible for postoperative wound culture after cardiac surgery? A multicentre mixed-methods feasibility study in the UK. BMJ Open. 2026 Feb 10;16(2):e112691. doi: 10.1136/bmjopen-2025-112691. |