Condition category
Skin and Connective Tissue Diseases
Date applied
13/01/2020
Date assigned
14/01/2020
Last edited
14/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 October 2021

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

Trial website

http://cteu.bris.ac.uk/our-studies/?trialType=General-surgery#General-surgery

Contact information

Type

Scientific

Primary contact

Prof Barnaby Reeves

ORCID ID

http://orcid.org/0000-0002-5101-9487

Contact details

Location A703
Bristol Trials Centre (BHI Hub)
Bristol Medical School
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
+44 (0)7855322705
barney.reeves@bristol.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

v1.0

Study information

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.

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

No ethics approval required. Secondary analysis of routinely collected data (UK hospital episode statistics)

Study design

Retrospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Severe pressure ulcers

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

Phase

Drug names

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 trial start date

01/09/2018

Overall trial end date

31/10/2021

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

All patients with a record as described will be eligible (estimated 35,000 per year)

Participant exclusion criteria

None

Recruitment start date

01/04/2012

Recruitment end date

31/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Trials Centre (BHI Hub)
Bristol Medical School Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust

Sponsor details

Education & Research Centre
Level 3
Upper Maudlin Street
Bristol
BS2 8AE
Bristol
BS2 8AE
United Kingdom
+44 (0)117 342 0233
research@uhbristol.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.uhbristol.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

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 statement:
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.

Intention to publish date

31/10/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/01/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)