Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.

Pressure ulcers are areas of tissue damage associated with pressure and shear forces and are an important potential complication for patients undergoing surgery. Patients undergoing surgical procedures may be at increased risk because they can remain immobile in one position for prolonged periods and are unable to respond to discomfort associated with pressure and shear while undergoing surgery.

The aim of this study is to determine the incidence of pressure ulcers at the heels among adult surgical inpatients using the Oasis Elite Heel Pad (EL130), with pressure ulcer development assessed using both subepidermal moisture (SEM) assessment and visual skin assessment (VSA). The study will also explore the usability, acceptability, and perceived value of the heel pad among multidisciplinary surgical theatre staff.

This is a single-site, multiphase study consisting of two phases.

Phase 1: Prospective observational study

Approximately 35 adult patients admitted for elective surgery will participate in Phase 1. Eligible participants will be adults aged 18 years or older who are admitted preoperatively for elective surgery, have a planned surgery duration of at least one hour, have an anticipated length of hospital stay of approximately three days, and are planned to use the Oasis Elite Heel Pads (EL130) as part of routine intraoperative pressure ulcer prevention.

The study does not require a change to standard clinical care. The Oasis Elite Heel Pads are already used at the study site for routine pressure ulcer prevention. Research assessments conducted during the study are additional to routine clinical assessments and do not direct or influence clinical care decisions.

Participants will undergo assessment of both heels using VSA and SEM assessment with the Provizio® SEM Scanner. A baseline assessment will be performed before surgery. Assessments will then be performed hourly during the intraoperative period and during postoperative follow-up for up to 72 hours.

VSA will assess the appearance of the skin at each heel and pressure ulcers will be classified using the NPUAP/EPUAP/PPPIA pressure ulcer classification system. SEM assessment is a non-invasive assessment performed using the Provizio® SEM Scanner. The scanner measures subepidermal moisture associated with inflammatory changes in tissue. Four measurements are collected from each heel and used to generate a SEM delta value.

The primary outcome of Phase 1 is the incidence of SEM- and VSA-detected pressure ulcers at the heels among adult surgical inpatients using the heel pad. A SEM-detected pressure ulcer will be defined as two sustained elevated SEM measurements over two consecutive days at the same anatomical location, with a SEM delta value of 0.6 or greater, among participants who had a normal SEM reading preoperatively. A VSA-detected pressure ulcer will be defined according to the NPUAP/EPUAP/PPPIA pressure ulcer classification system.

Secondary outcomes include observation of hourly SEM delta values during surgery while participants are using the heel pad and the length of time to development of a pressure ulcer at the heels during the intraoperative and postoperative study period.

Relevant demographic and surgical information will also be collected to describe the study population and provide context for the study findings. This includes age, sex, skin tone, surgery type, position during surgery, time spent in surgery, and the type of heel pad used at the heels intraoperatively.

Phase 2: Qualitative usability study

Phase 2 will explore the usability, acceptability, and perceived value of the Oasis Elite Heel Pad among multidisciplinary surgical theatre staff involved in the care of participants recruited during Phase 1.

Approximately 15 multidisciplinary surgical theatre staff who have used the heel pad intraoperatively during the Phase 1 data collection period will be invited to participate. Recruitment will continue until sufficient qualitative data have been obtained.

Following informed consent, staff participants will take part in an individual semi-structured interview lasting no more than approximately 30 minutes. Interviews will explore staff perceptions of the usability, acceptability, and perceived value of the heel pad for intraoperative pressure ulcer prevention, including usability issues and contextual barriers or facilitators that may influence its adoption and continued use in clinical practice.

Interview transcripts will be analysed using thematic analysis to identify themes relating to staff experiences and perceptions of the heel pad and potential opportunities for design or workflow improvements.

The study will be conducted at Connolly Hospital Dublin. The overall study, including preparation, data collection, analysis, and write-up, is planned to be completed within approximately 12 months.