Surgical interventions to treat severe pressure sores – The SIPS study

Study type
Protocol
Date of Approval
Study reference ID
20_097
Lay Summary

Being immobile for too long can lead to discomfort, for example pins and needles or pain. These sensations prompt us to move, so avoiding poor blood flow which can lead to pressure ulcers. Pressure ulcers mainly affect older people confined to a bed or chair. However, younger or seriously ill patients with limited movement can be affected. Pressure ulcers range in severity from red skin to deep wounds through muscle to bone. Pressure ulcers have a major impact on quality of life; they may heal slowly, become infected and can increase the risk of dying in older people. They are also a costly problem for the National Health Service (NHS).

Common treatments for pressure ulcers include pressure relief, dressings and encouraging change of position. Surgery can be used to try and close deep pressure ulcers but in the United Kingdom this treatment is not common. It is not currently clear which patients with pressure ulcers may benefit from an operation and which of the different ways of doing the surgery seems best.

This study will analyse data collected routinely in the NHS about people who developed a pressure ulcer during the last 11 years. The study will describe the care that has been provided to these patients, the number of ulcers progressing to severe status, the kinds of patients who have been treated in different ways and examine how care is different in different places. It will also compare health outcomes in patients who did and did not have surgery.

Technical Summary

There is little evidence about the effectiveness of surgical interventions for stage III and IV pressure ulcers. This retrospective cohort study is part of the SIPS study, which aims to define the parameters required for a randomised controlled trial of surgery for this indication.

The study will request data for patients with an index record indicating a pressure ulcer during a period of 11 years, linked to Hospital Episode Statistics (HES) records and mortality records. We expect the cohort to comprise over 75,000 pressure ulcers, using Read and SNOMED codes to ascertain eligible patients with incident ulcers.

This cohort will be used to assess usual care provided to patients, including but not limited to referrals within primary care, dressings, provision of pressure relief equipment and negative wound pressure therapy.

The objective is to describe the patients with incident severe pressure ulcers and their care pathways across primary and secondary care, e.g. management in the community, management by tissue viability nurses, admission to hospital and subsequent care.

The outcomes described will be:
1. frequencies of specific Read and SNOMED codes;
2. referral to and discharge from community/district nursing team;
3. referral to tissue viability services;
4. admission to hospital with a pressure ulcer diagnosis, and duration of admissions;
5. admission to hospital for surgical reconstruction of a pressure ulcer;
6. mortality.

Mortality is an important outcome as pressure ulcers increase the risk of dying in older people. Outcome frequencies will be estimated precisely, given the large sample size. A small number of patients who have hospital admissions will be tracked through linkage with HES data.

These findings will contribute to a formal consensus process to define the populations that may benefit from reconstructive surgery, the operations that should be considered and what should constitute usual care.

Health Outcomes to be Measured

1. Frequencies of activities (indicated by Read or SNOMED codes) reflecting management of pressure ulcers;
2. Referral to and discharge from community/district nursing team, generating periods of community nursing care and durations;
3. Referral to tissue viability services;
4. Admission to hospital with a pressure ulcer diagnosis, and duration of admissions related to a pressure ulcer;
5. Admission to hospital for surgical reconstruction of a pressure ulcer;
6. Mortality.

Collaborators

Barnaby Reeves - Chief Investigator - University of Bristol
Jessica Harris - Corresponding Applicant - University of Bristol
Jason Kin Fai Wong - Collaborator - University of Manchester
Jeremy Rodrigues - Collaborator - Nuffield Dept of Orthopaedics
Jessica Harris - Collaborator - University of Bristol
Jo Dumville - Collaborator - University of Manchester
Louise O'Connor - Collaborator - University of Manchester
Maria Pufulete - Collaborator - University of Bristol
Matthew Ridd - Collaborator - University of Bristol
Nicky Cullum - Collaborator - University of Manchester
Rosie Harris - Collaborator - University of Bristol
Ross Atkinson - Collaborator - University of Manchester
Una Adderley - Collaborator - University of Leeds

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation