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Clinical Trial

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

NCT: NCT07852897 · ENROLLING_BY_INVITATION

NCT IDNCT07852897
StatusENROLLING_BY_INVITATION
Start Date2026-06-09
Completion2027-06-09
SponsorTrulife (INDUSTRY)
First posted
Last updated

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.

Frequently Asked Questions

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

Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients. is a clinical trial registered under NCT07852897. Current status: ENROLLING_BY_INVITATION.

What is the status of NCT07852897?

The current status of NCT07852897 (Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.) is: ENROLLING_BY_INVITATION.

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

Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients. started on 2026-06-09.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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