Evaluating whether surgical reconstruction is better than non-surgical treatment for people admitted to hospital who have a severe pressure ulcer
| ISRCTN | ISRCTN13292620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13292620 |
| Secondary identifying numbers | v1.0 |
- Submission date
- 13/01/2020
- Registration date
- 14/01/2020
- Last edited
- 03/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Being immobile for too long can lead to discomfort, for example pins and needles or pain. These sensations prompt us to move and this avoids poor blood flow which can lead to pressure ulcers (sometimes called bed sores). Pressure ulcers mainly affect older people confined to a bed or chair. However, younger or seriously ill patients with limited movement, for example due to a spinal injury, can be affected.
Pressure ulcers are a serious problem for patients and their carers. They range in severity from red skin (Stage 1) to deep wounds through muscle to bone (Stage 4). Pressure ulcers have a major impact on quality of life; they may heal slowly and become infected, and can increase the risk of dying in older people. They are also a costly problem for the National Health Service (NHS). People with pressure ulcers are usually treated in the community but may need hospital care. Common treatments for pressure ulcers include pressure relief, dressings and encouraging movement and change of position. Surgery can be used to try and close deep pressure ulcers but in the United Kingdom (UK) this treatment is not common. Finding out whether surgery works as a treatment is very important to people affected by pressure ulcers. At the moment, it is not clear which patients with pressure ulcers may benefit from an operation and which of the different ways of doing the surgery seems best.
Who can participate?
Records from patients described in Hospital Episode Statistics with index admission (admitted patient care dataset) with a severe pressure ulcer between April 2012 and March 2019.
What does the study involve?
The SIPS study will analyse data collected routinely in the NHS over the last 7 years. The study will describe the care that has been provided in England to patients with severe pressure ulcers, the kinds of patients who have been treated in different ways and examine how care is different in different places. To inform whether surgical treatments should be more widely available, the study will identify patients who were similar when admitted to hospital with a severe pressure ulcer and compare health outcomes (such as going back to hospital and death) among those who did and did not have surgery.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Bristol Trials Centre (BHI Hub), UK
When is the study starting and how long is it expected to run for?
April 2020 to June 2023
Who is funding the study?
National Institute for Health Research (HTA programme), UK
Who is the main contact?
Prof. Barnaby Reeves
barney.reeves@bristol.ac.uk
Contact information
Scientific
Location A703
Bristol Trials Centre (BHI Hub)
Bristol Medical School
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
 ORCID ID |
0000-0002-5101-9487 |
|---|---|
| Phone | +44 (0)7855322705 |
| barney.reeves@bristol.ac.uk |
Study information
| Study design | Retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Health outcomes in matched groups of patients admitted to hospital who have a severe pressure ulcer who do or do not have a surgical reconstruction operation. |
| Study acronym | SIPS |
| Study hypothesis | Surgical reconstruction improves long term health outcomes in people who have a severe pressure ulcer during a hospital admission |
| Ethics approval(s) | No ethics approval required. Secondary analysis of routinely collected data (UK hospital episode statistics) |
| Condition | Severe pressure ulcers |
| Intervention | Current intervention as of 16/12/2020: Reconstructive surgery operations coded with OPCS-4 codes: S17, S18, S19, S20, S21, S22, S23, S24, S25, S26 and S27. Surgical debridement (OPCS code S57.1) will also be described. Participants will have been treated in hospital for a severe pressure ulcer (potentially among other diagnoses). Our intention is to capture all diagnoses at ‘enrolment’ (to characterise participants at the time of the index hospital admission) and then describe all procedures administered in that admission and subsequently, and describe outcomes such as duration of index admission, and time to readmission with a pressure ulcer related diagnosis. _____ Previous intervention: Reconstructive surgery operations coded with OPCS-4 codes: S17, S18, S19, S20, S21, S22, S23, S24, 25, S26. Surgical debridement (OPCS code S57.1) will also be described. Participants will have been treated in hospital for a severe pressure ulcer (potentially among other diagnoses). Our intention is to capture all diagnoses at ‘enrolment’ (to characterise participants at the time of the index hospital admission) and then describe all procedures administered in that admission and subsequently, and describe outcomes such as duration of index admission, and time to readmission with a pressure ulcer related diagnosis. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Time to first subsequent admission with a pressure-ulcer related diagnosis measured using patient records |
| Secondary outcome measures | Measured using patient records: 1. Type of surgical reconstruction (OPCS code), if any 2. Duration of index admission 3. Time to first subsequent admission with a pressure-ulcer related diagnosis 4. Rate of subsequent admissions with a pressure-ulcer related diagnosis 5. Surgical reconstruction after discharge for the index admission 6. Mortality |
| Overall study start date | 01/09/2018 |
| Overall study end date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | All patients with a record as described will be eligible (estimated 35,000 per year) |
| Total final enrolment | 291326 |
| Participant inclusion criteria | Current participant inclusion criteria as of 16/12/2020: Patients described in Hospital Episode Statistics with index admission (admitted patient care dataset) with a severe pressure ulcer (ICD-10 codes L89.2, L89.3, L89.9) or any pressure ulcer (L89.X) during a period of 8 years (01/04/2011-31/03/2019), linked with other HES APC and outpatient episodes and mortality data (to 31/03/2019). The target population for the HES cohort is: patients aged >=18 years in England admitted to hospital, with an ICD-10 diagnosis code for a severe pressure ulcer. _____ Previous participant inclusion criteria: Patients described in Hospital Episode Statistics with index admission (admitted patient care dataset) with a severe pressure ulcer (ICD-10 codes L89.2, L89.3, L89.9) during a period of 7 years (01/04/2012-31/03/2019). |
| Participant exclusion criteria | There are no secondary outcome measures |
| Recruitment start date | 01/04/2011 |
| Recruitment end date | 31/03/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
Sponsor information
Hospital/treatment centre
Education & Research Centre, Level 3
Upper Maudlin Street
Bristol, BS2 8AE
Bristol
BS2 8AE
England
United Kingdom
| Phone | +44 (0)117 342 0233 |
|---|---|
| research@uhbristol.nhs.uk | |
| Website | http://www.uhbristol.nhs.uk/ |
"ROR" |
https://ror.org/04nm1cv11 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Some co-applicants are contributing to NHS England’s National Wound Care Strategy, which will provide a key avenue to communicate findings. We will report findings at conferences and in high-impact general journals. We will impact on clinical practice by engaging with professional bodies; study collaborators have strong links with organisations including the Tissue Viability Society and NICE. We will ensure members of our Patient and Public Involvement (PPI) forum are actively involved in carrying out activities relating to dissemination and public engagement. Opportunities such as talks to local groups and other events will be considered on a case by case basis. A lay summary of the research and its findings will be written and added to collaborator University websites and relevant blogs. To maximise visibility and accessibility of the material, we will use Google metrics to ensure our wording on the relevant site means the web page is located high in the returned list from a Google search. We also have close links with local Trusts and will aim to distribute the summary locally at relevant patient events in addition to online content. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to restrictions imposed by the data source. To support further engagement work we will liaise with experienced colleagues at the NIHR Manchester Biomedical Research Centre and Public Programmes at Manchester University NHS Foundation Trust to undertake a range of engagement activities at public events including the Manchester Science Festival. These activities will raise the profile of pressure ulcers and research to improve their management. We will link with existing networks at the University of Manchester to ensure our findings are presented locally to both academics, clinicians and members of the public, for example the Manchester Institute for Collaborative Research on Ageing, seminars for which are regularly well-attended by each of these groups. We will publish relevant journal articles and attend at least one key conference. We will also draft media-friendly articles for relevant trade journals such as the Nursing Times and Nursing Standard. We will summarise the work using widely accessed, research-focused resources such as The Conversation and Kudos. We will also contact the NIHR Dissemination Centre to ask for advice where there are specific findings we want to publicise. Publications will be supported by targeted social media activity, especially through Twitter, using current accounts that link to a wide range of relevant stakeholder groups to ensure wide dissemination alongside a study specific account. Where required, press releases and media support will be provided. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 04/11/2020 | 17/08/2022 | No | No |
Additional files
Editorial Notes
03/07/2024: The intention to publish date was changed from 30/06/2024 to 30/09/2024.
04/03/2024: The intention to publish date was changed from 31/03/2024 to 30/06/2024.
05/12/2023: The intention to publish date was changed from 31/12/2023 to 31/03/2024.
06/06/2023: The following changes were made to the study record:
1. Total final enrolment added.
2. The overall study end date was changed from 31/10/2022 to 30/06/2023.
3. The intention to publish date was changed from 30/06/2023 to 31/12/2023.
14/10/2022: The contact confirmed the record is up to date.
01/09/2022: The intention to publish date was changed from 30/09/2022 to 30/06/2023.
17/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
17/08/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/04/2022 to 31/10/2022.
2. The plain English summary was updated to reflect these changes.
06/10/2021: The following changes have been made:
1. The overall trial end date has been changed from 31/10/2021 to 30/04/2022 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 31/10/2021 to 30/09/2022.
16/12/2020: The following changes have been made:
1. The intervention has been changed.
2. The trial website has been changed.
3. The participant inclusion criteria have been changed.
4. The recruitment start date has been changed from 01/04/2012 to 01/04/2011.
14/01/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)
