Haftungsausschluss: Diese Website bündelt öffentlich verfügbare Daten aus offiziellen Quellen wie FDA, ClinicalTrials.gov, PubMed und SEC EDGAR nur zur allgemeinen Information. Sie stellt keine medizinische Beratung, Diagnose, Behandlungsempfehlung oder Anlageberatung dar.

Klinische Studie

Beurteilung kommerziell verfügbare Fußpolster zur Prävention von Druckgeschwüren: Eine beobachtende Studie zur Häufigkeit und Benutzerfreundlichkeit bei erwachsenen chirurgischen Patienten.

NCT: NCT07852897 · ENROLLING_BY_INVITATION

NCT-IDNCT07852897
Medizinische Daten: StatusENROLLING_BY_INVITATION
Startdatum2026-06-09
Abschluss2027-06-09
SponsorTrulife (INDUSTRY)
First posted
Last updated

Kurzzusammenfassung

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.

Offizielle Quelle

Auf ClinicalTrials.gov ansehen →

Daten aus der ClinicalTrials.gov-API. Den aktuellsten Status finden Sie im offiziellen Eintrag.

↑