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Clinical Trial Summary

This study will evaluate the use of a mattress overlay system to promote the healing of full thickness pressure ulcers. The overlay is placed over the patient's bed making it easier for patients to get in and out of bed. In addition, the overlay has blue tooth capabilities that will allow clinicians to remotely monitor adherence with the device.


Clinical Trial Description

The study is a multi-center, prospective, study designed to evaluate the use of an alternating mattress overlay in the treatment of stage 3 pressure ulcers. After screening, eligible subjects will receive a mattress overlay system for the 4 weeks of treatment. The mattress is fitted to the patient's bed/mattress in his/her home or skilled nursing facility (SNF). Patients responding to the offloading regimen (percent wound area reduction >20% at 4 weeks) may use the overlay for up to 12 additional weeks. The SOC in this study is debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05033470
Study type Interventional
Source SerenaGroup, Inc.
Contact Thomas Serena, MD, FACS
Phone 814-688-4000
Email serena@serenagroups.com
Status Recruiting
Phase N/A
Start date October 4, 2021
Completion date June 30, 2023

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