A tool to predict the risk of surgical wound infection enabling infection prevention strategies in heart surgery
| ISRCTN | ISRCTN13950775 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13950775 |
| IRAS number | 295054 |
| Secondary identifying numbers | CPMS 50656, IRAS 295054 |
- Submission date
- 28/10/2021
- Registration date
- 04/03/2022
- Last edited
- 28/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims:
Surgical site infections (SSIs) are commonly associated with heart surgery patients. Statistics indicate that wound infection is linked to increased death rates and other health complications. Also, this is expensive for healthcare systems as they are stretched to provide care for patients with complex wound infections. Therefore, this study aims to explore how wound infections can be prevented, and what difficulties healthcare staff might be having in monitoring infections in patients.
Who can participate?
Patients aged 18-85 years old who are having coronary bypass graft surgery (CABG), specifically those who have been invited for surgery. Participants who are admitted on an urgent basis will also be considered to take part in this study. However, participants who have been admitted as an emergency case will be excluded from the study as It’s not possible to monitor their pre-surgical journey.
What does the study involve?
There are three parts to this study; firstly, the researcher will look at the current evidence to see what the risk factors are for wound infections amongst heart surgery patients. In the second part of the study, they will watch some operations and follow the patient through their journey to see what it’s like for them. Following on from this, patients will be interviewed once they are discharged home to get their views on how wound infections can be prevented. Also, hospital staff will be interviewed to get an understanding of their views too. The third part of the study involves an audit of 29 heart surgery centres in England to see what the practice is like nationally. Staff and service users will complete a survey. Interviews will also be carried out with 16 staff and 4 service users to understand the difficulties they may face in caring for wound infections and monitoring them.
What are the possible benefits and risks of participating?
The study is low risk, and in the event of a potential concern that may arise during the observations or interviews then the researcher will contact the safeguarding lead at the participating site. The benefit of participating in the study is that health professionals and clinicians can identify the most effective wound infection preventive strategies in heart surgery patients which can help to improve patients’ overall health and quality of life.
Where is the study run from?
The University of Nottingham (UK)
When is the study starting and how long is it expected to run for?
January 2021 to June 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Prof. Gavin Murphy, gjm19@hotmail.com
2. Prof. Judith Tanner judith.tanner@nottingham.ac.uk
Contact information
Scientific
Department of Cardiovascular Sciences
University of Leicester
Clinical Sciences Wing
Glenfield General Hospital
Leicester
LE3 9QP
United Kingdom
| Phone | +44 (0)116 258 3054 |
|---|---|
| gjm19@le.ac.uk |
Scientific
Work package 2 and 3 lead
Faculty of Medicine and Health Sciences
University of Nottingham
Queen’s Medical Centre
Nottingham
NG7 2UH
United Kingdom
| judith.tanner@nottingham.ac.uk |
Study information
| Study design | Observational; Design type: Qualitative |
|---|---|
| Primary study design | Observational |
| Secondary study design | Qualitative study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A surgical site infection risk prediction tool to enable targeted infection prevention strategies in adult cardiac surgery |
| Study acronym | Target SSI |
| Study objectives | WP 1: What are the risk factors that predict wound infection in adult patients having cardiac surgery? WP 2: What is usual care for patients undergoing cardiac surgery? What are the barriers and facilitators to implementing interventions to prevent wound infections? WP 3: What are the barriers and facilitators to accurate wound infection surveillance? |
| Ethics approval(s) |
Approved 05/11/2021, East of Scotland REC 1 (East of Scotland Research Ethics Service, Tayside Academic Health Sciences Centre, Residency Block Level 3, George Pirie Way, Ninewells Hospital& Medical School, Dundee, DD1 9SY, United Kingdom; +44 (0)1382 383871; tay.eosres@nhs.scot), ref: 21/ES/0098 |
| Health condition(s) or problem(s) studied | Adult cardiac surgery |
| Intervention | This is a qualitative study involving observations and interviews. 32 patients across four cardiac centres in England will be observed by the study researchers. The observation period for each patient will not exceed 1 day. Patients will be observed as they progress from the admission ward to the theatre and to the surgical ward. Observations will focus on the interventions given to the patient that prevent wound infections. The 32 observed patients will be given an opportunity to take part in an interview after they have been discharged home. Four patients will be interviewed. The interviews will take place online and last 30-60 min. The focus of the interviews is potential patient contribution to interventions to prevent wound infection. The researchers will interview 20 staff across the four cardiac centres. The interviews will take place online and last 30-60 min. The focus of the interviews is compliance with interventions to prevent wound infection. The researchers will invite surveillance/infection prevention leads at all 29 cardiac centres in England to complete an audit describing their wound infection surveillance practices for cardiac surgery. The researchers will distribute a staff surveillance survey and a service user surveillance survey. The surveys are online and will take 20 min to complete. The focus is barriers and facilitators to compliance with surveillance and how patients and carers can get involved with surveillance. They will be distributed via the study web page (hosted by the University of Leicester) and also sent out via the Cardiac Interdisciplinary Research Network, the National Cardiac Benchmarking Collaboration and infection prevention leads and cardia surgery leads at all 29 cardiac centres in England. The researchers will interview 16 staff about compliance with wound infection monitoring and reporting. The interviews will take place online and last 30-60 min. The researchers will recruit participants through the surveillance survey. The researchers will interview four service users about compliance with wound infection monitoring and reporting. The interviews will take place online and last 30-60 min. The researchers will recruit participants through the surveillance survey. |
| Intervention type | Other |
| Primary outcome measure | 1. Process map of the cardiac surgical patient journey, measured in month 6 using data from patient observations in months 1, 2 and 3 2. Barriers and facilitators to the implementation of interventions to prevent wound infections, measured by staff and patient interviews during months 2, 3 and 4 of WP 2 3. Barriers and facilitators to the implementation of wound infection surveillance. measured by staff and Patient and Public Involvement (PPI) survey in month 1 of WP 3 and also by staff and PPI interviews in months 1 and 2 of WP 3 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2021 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient, Health professional, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 72; UK Sample Size: 72 |
| Key inclusion criteria | Patients for observations: Patients are eligible if they: 1. Are having CABG surgery at a participating site during the study observation period 2. Are an elective or an urgent surgery patient 3. Are able to give informed consent 4. Are between 18 and 85 years 5. Have, or do not have, an existing infection 6. Have, or do not have, an existing condition or disability 7. Are any gender, ethnicity or socioeconomic group 8. Able to speak English (or have translator/interpreter available) Patients for intervention interviews: Patients are eligible if they: 1. Took part in the patient observations component of the study 2. Have been discharged from hospital 3. Have access to online interview facilities Staff for interventions interviews: Staff are eligible if they: 1. Work at a participating site 2. Contribute to the cardiac surgical patient journey 3. Represent a professional group identified through the observations 4. Have access to online interview facilities 5. Are any gender, ethnicity or age range Surveillance audit: Staff are eligible if they: 1. Are the surveillance lead or infection prevention lead at a cardiac centre in England Staff surveillance survey: Staff are eligible if they: 1. Are the surveillance lead or infection prevention lead at a cardiac centre in England, or 2. Contribute to the cardiac surgical patient journey, or 3. Contribute to cardiac surveillance programme Service user surveillance survey: Any service user is eligible to take part, whether they have had surgery or not, or whether they care for someone who has had surgery or not, any gender or ethnicity Staff for wound monitoring interviews: Staff are eligible if they: 1. Took part in the surveillance survey and volunteered to take part in an interview 2. Work in a cardiac centre 3. Have access to online interview facilities 4. Are any gender, ethnicity or age range Service users for wound monitoring interviews: Service users are eligible if they: 1. Took part in the surveillance survey and volunteered to take part in an interview 2. Have been a surgical patient (any specialty), have been a carer for a surgical patient, are a member of the public 3. Have had, or have not had a surgical wound infection 4. Have access to online interview facilities 5. Can give informed consent 6. Are between 18 and 85 years 7. Are any gender, ethnicity or socioeconomic group |
| Key exclusion criteria | Patients for observations: Patients are not eligible if they: 1. Are not having CABG surgery at a participating site during the study observation period 2. Are having emergency surgery 3. Are not able to give consent 4. Are younger than 18 years or older than 85 years Patients for intervention interviews: Patients are not eligible if they: 1. Did not take part in the patient observations component of the study 2. Do not have access to online interview facilities 3. Have not been discharged from hospital Staff for interventions interviews: Staff are not eligible if they: 1. Do not work at a participating site 2. Do not contribute to the cardiac surgical patient journey 3. Do not have access to online interview facilities 4. Do not represent a professional group identified through the observations WP 3 Surveillance audit: Staff are not eligible if they: 1. Are not the surveillance lead or infection prevention lead at a cardiac centre in England WP 3 Staff surveillance survey: Staff are not eligible if they: 1. Are not the surveillance lead or infection prevention lead at a cardiac centre in England, or 2. Do not contribute to the cardiac surgical patient journey, or 3. Do not contribute to the cardiac surveillance programme Surveillance audit: Staff are not eligible if they: 1. Are not the surveillance lead or infection prevention lead at a cardiac centre in England Staff surveillance survey: Staff are not eligible if they: 1. Are not the surveillance lead or infection prevention lead at a cardiac centre in England, or 2. Do not contribute to the cardiac surgical patient journey, or 3. Do not contribute to the cardiac surveillance programme Staff for wound monitoring interviews: Staff are not eligible if they: 1. Did not take part in the surveillance survey and did not offer to take part in an interview 2. Do not work in a cardiac centre 3. Do not have access to online interview facilities Service users for wound monitoring interviews: Service users are not eligible if they: 1. Did not take part in the surveillance survey and did not offer to take part in an interview 2. Do not have access to online interview facilities 3. Are unable to give consent 4. Are younger than 18 years or older than 85 years |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
London
SW3 6NP
United Kingdom
Liverpool
L14 3PE
United Kingdom
Harefield
Uxbridge
UB9 6JH
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Sponsor information
University/education
Research Governance Office
Leicester General Hospital
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 (0)1162584099/258 4867 |
|---|---|
| rgosponsor@leicester.ac.uk | |
| Website | http://www.le.ac.uk/ |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The Patient and Public Involvement (PPI) researchers will contribute to the analysis and the findings will be presented at the Society of Cardiothoracic Surgeons Annual Conference and will continue to be disseminated via CIRN webinars throughout the study and after the study finishes. Also, the PPI members will represent the project at the national cardiac surgery PPI group hosted by the British Heart Foundation (BHF) Clinical Research Collaborative. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/11/2023 | 07/12/2023 | Yes | No | |
| Other publications | 25/01/2025 | 28/01/2025 | Yes | No |
Editorial Notes
28/01/2025: Publication reference added.
27/06/2023: The following changes were made to the trial record:
1. The ethics approval was added.
2. The study participating centres Royal Sussex County Hospital, John Radcliffe Hospital, University of Nottingham were removed and Harefield Hospital, University Hospitals Bristol and Weston NHS Foundation Trust were added.
3. The participant level data sharing statement was added.
4. The study website was added.
28/10/2021: Trial's existence confirmed by the NIHR.
