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Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit

NCT06438042 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-06-18

No results posted yet for this study

Summary

The aim of the study is to determine the clinical value of using a a low air pressure motorised therapeutic mattress in the prevention of pressure injury (PI) in patients at medium to high risk.

This study is noncomparative, observational study.

Patients older than 18 years of age, with a high risk of PI, without PI, lying more than 20 hours a day on a XTECH®25 mattress will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department.

Patients are followed up for 35 days. The use of the XTECH®25 mattress is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

Conditions

  • Pressure Ulcer

Interventions

DEVICE

Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies

Patients with a high risk of pressure injury, without pressure injury, lying more than 20 hours a day, will ly a on a XTECH®25 mattress

Sponsors & Collaborators

  • Clin-Experts

    collaborator INDUSTRY

  • SYSTAM

    lead INDUSTRY

Principal Investigators

  • Sylvie MEAUME · Hôpital ROSCHILD

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • France

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06438042 on ClinicalTrials.gov