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

NCT07852897 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: TruE130
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Injury Prevention

Keywords

Pressure Injury Prevention

Outcome Measures

Primary Outcomes (1)

• Incidence of heel pressure ulcers detected by SEM assessment and visual skin assessment.

  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.

  From preoperative baseline through 72 hours postoperatively

Study Arms (1)

Adult surgical patients using Oasis Elite Heel Pads

Adult patients undergoing elective surgery who use the Oasis Elite Heel Pad (EL130) as part of routine intraoperative pressure ulcer prevention. Participants will undergo visual skin assessment (VSA) and subepidermal moisture (SEM) assessment of both heels before surgery, hourly during surgery, and during postoperative follow-up for up to 72 hours. Use of the heel pad is part of standard care at the study site and is not assigned as a research intervention.

Device: Oasis Elite Heel Pad (EL130)

Interventions

Oasis Elite Heel Pad (EL130) DEVICE

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.

Adult surgical patients using Oasis Elite Heel Pads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Phase 1 will include a convenience sample of adult patients undergoing elective surgery at Connolly Hospital Dublin who are planned to use the Oasis Elite Heel Pad (EL130) as part of routine intraoperative pressure ulcer prevention. Participants will be followed from the preoperative period through 72 hours postoperatively. Phase 2 will include approximately 15 multidisciplinary surgical theatre staff who were involved in the surgery of Phase 1 participants and who used the heel pad intraoperatively. Staff who volunteer to participate will complete a semi-structured interview about the usability, acceptability, and perceived value of the heel pad.

You may qualify if:

• Adult patients aged 18 years or older
• Admitted preoperatively for elective surgery
• Planned surgery duration of at least 1 hour
• Anticipated/planned length of hospital stay of 3 days
• Able to provide informed consent to participate
• Intraoperative use of the Oasis Elite Heel Pad (EL130) planned as part of routine pressure ulcer prevention

You may not qualify if:

• Undergoing emergency surgery
• Planned surgical position that does not require heel pads intraoperatively (e.g., prone position)
• Anticipated/planned length of hospital stay of less than 3 days at study enrolment
• Visual pressure ulcers present on both heels at baseline
• Unable to provide informed consent
• Oasis Elite Heel Pads (EL130) not being used intraoperatively

Sponsors & Collaborators

• Trulife: lead
• Royal College of Surgeons, Ireland: collaborator

Study Sites (1)

Connolly Hospital Dublin

Dublin, Ireland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 1, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): June 9, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)