An Evaluation of the Impact of a Wound Dressing on Pressure Ulcer Incidence.
An Evaluation of the Impact of a Wound Dressing on Pressure Ulcer Incidence.
A pressure ulcer (PU) is localized injury to the skin and/or underlying tissue usually over a
 bony prominence, as a result of pressure, or pressure in combination with shear. PUs are
 common, affecting up to 40% of participants receiving health care. Furthermore, PUs impact
 negatively on an individual's health related quality of life, with pain being the most
 frequently cited complaint. PUs commonly occur in those who cannot reposition themselves to
 relieve pressure/shear over bony prominences. The ability to reposition is often diminished
 in the very old, the malnourished and those with acute illness. Pressure ulcers are common
 devastating wounds, extending from deep in the bone and muscle layers through to the skin,
 occurring most often in older persons with limited mobility. They contribute to significant
 morbidity and mortality as they are smelly, highly painful and very prone to infection.

 Existing research carried out by the RCSI School of Nursing and Midwifery shows that both
 high and low movers are at risk of pressure ulcer development.
A pressure ulcer (PU) is localized injury to the skin and/or underlying tissue usually over a
 bony prominence, as a result of pressure, or pressure in combination with shear. PUs are
 common, affecting up to 40% of participants receiving health care. Furthermore, PUs impact
 negatively on an individual's health related quality of life, with pain being the most
 frequently cited complaint. PUs commonly occur in those who cannot reposition themselves to
 relieve pressure/shear over bony prominences. The ability to reposition is often diminished
 in the very old, the malnourished and those with acute illness. Pressure ulcers are common
 devastating wounds, extending from deep in the bone and muscle layers through to the skin,
 occurring most often in older persons with limited mobility. They contribute to significant
 morbidity and mortality as they are smelly, highly painful and very prone to infection.

 Existing research carried out by the RCSI School of Nursing and Midwifery shows that both
 high and low movers are at risk of pressure ulcer development.

 The wound dressing used in this study has been developed to facilitate exudate management in
 the treatment of wounds. Newly formed tissue enjoys optimal protection under a moist
 environment. The foam core with super-absorbers ensures reliable absorption in slightly to
 heavily exuding wounds. This core has an excellent retention capacity, even under
 compression. Hydrogen bridges bind the water so securely that, even when subject to pressure,
 the water is not released. Vertical absorption through the polyurethane foam and the hydro-
 phobic wound contact layer minimizes the risk of macerations in the peri-ulcer skin.

 This study is interested in pressure ulcer incidence among low and high movers, residing in a
 long stay health care facility. The dressing will be applied to intact skin over
 participant's sacrum and heels as these areas are shown to be at highest risk of pressure
 ulcer development, in the study population. Participants will be followed up for 20 days,
 during which time the participant's sacrum and heels will be assessed daily with a non
 invasive SEM scanner, the EPUAP grading tool, and the usual additional pressure ulcer
 prevention care. To measure if the participant is a low or high mover an EasySense mobility
 sensor will be placed under the participant's mattress.

 The overall aim of the study is to the impact of the dressing on pressure ulcer incidence in
 the study population. From a health economics perspective, the management of PUs is suggested
 to consume 4% of health budgets across Europe, annually. In Ireland PUs of stage 3 and 4 are
 considered to be serious reportable adverse healthcare events and as such impact negatively
 on participant safety goals. Furthermore, a recent report from the OECD suggests that PUs are
 among the most burdensome adverse event type in healthcare, secondary to venous
 thromboembolism. As such, PUs are a significant threat to participant safety, with prevention
 being substantially cheaper than treatment5. Indeed, in Europe the cost of PU treatment
 across all levels of care is estimated at 121.44 million to 2.59 billion EUR, whereas
 prevention is estimated at 195.27 to 291.33 million EUR5.
Inclusion Criteria:

 Participants will be considered eligible if they fulfil the following criteria:

 -  male or female subject aged at least 18 years

 -  willing and able to give written informed consent and to comply with the requirements

 -  being at risk of PU development as measured by the activity and mobility components of
 a mobility assessment tool

 Exclusion Criteria:

 Participants will be ineligible for enrolment if they meet any of the following criteria:

 -  unable to provide written informed consent

 -  known hypersensitivity to any of the ingredients

 -  participant in any clinical trial of an investigational medicinal product (CTIMP or
 clinical investigation within 30 days prior to screening)