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

Condition(s) studied

Investigational drug(s) / intervention(s)

Oasis Elite Heel Pad (EL130): The Oasis Elite Heel Pad (EL130) is a reusable, non-sterile heel pad used as part of routine intraoperative pressure ulcer prevention. The device supports the Achilles tendon and distributes pressure away from the heel across a larger surface area. Use of the heel pad is part of standard care at the study site and is not assigned by the study investigators. The study will observe the incidence of heel pressure ulcers among surgical patients using the device.

Study summary

This study will evaluate the incidence of heel pressure ulcers in adult patients undergoing elective surgery while using the Oasis Elite Heel Pad (EL130) as part of routine pressure ulcer prevention. The study will also explore the usability, acceptability, and perceived value of the heel pad among multidisciplinary surgical theatre staff.

The study has two phases. Phase 1 is a prospective observational study involving approximately 35 adult surgical patients. The use of the heel pad is part of standard care and participation in the study will not alter participants' routine clinical care. Pressure ulcer development at both heels will be assessed using visual skin assessment (VSA) and subepidermal moisture (SEM) assessment with the Provizio® SEM Scanner. Assessments will be performed before surgery, hourly during surgery, and during postoperative follow-up for up to 72 hours.

The primary outcome of Phase 1 is the incidence of heel pressure ulcers detected by SEM assessment and VSA. The study will also examine changes in SEM measurements during surgery and the time to development of a heel pressure ulcer during the study follow-up period.

Phase 2 is a qualitative usability study involving approximately 15 multidisciplinary surgical theatre staff who have used the heel pads during the Phase 1 study period. Participants will take part in individual semi-structured interviews exploring the usability, acceptability, and perceived value of the heel pads for intraoperative pressure ulcer prevention.

Eligibility

Primary outcome measure(s)

• Incidence of heel pressure ulcers detected by SEM assessment and visual skin assessment. — From preoperative baseline through 72 hours postoperatively
  Incidence of heel pressure ulcers (PUs) detected using subepidermal moisture (SEM) assessment and visual skin assessment (VSA). Incidence will be calculated as the number of new PUs observed during the study period divided by the number of participants at risk at baseline, multiplied by 100. A SEM-detected PU is defined as two sustained elevated SEM measurements (delta ≥0.6) over two consecutive days at the same anatomical location among participants with a normal SEM reading preoperatively. A VSA-detected PU is defined as a grade 1-6 PU according to the NPUAP/EPUAP/PPPIA classification system.

Trial sites (1)