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Enrolling By Invitation
NCT07852897
Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
Conditions: Pressure Injury Prevention
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 35
Sponsor: Trulife
Location: Connolly Hospital Dublin Dublin
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 Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07852897). StuddyBuddy aggregates publicly available trial information.