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A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers

NCT05033470 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-04

No results posted yet for this study

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.

Conditions

  • Pressure Ulcer

Interventions

DEVICE

Dabir Mattress Overlay System

Dabir Surface mattress overlay system consists of a controller and a low-profile alternating pressure (AP) surface (placed over a non-powered mattress) with hundreds of air-filled geometric nodes arranged in rows. . The multiple rows of nodes inflate and deflate in alternating sequence every five minutes. During deflation phase, the skin and soft tissues experience reduced pressure/loading and enhanced perfusion. In conjunction with Standard of Care: Debridement, Proper moisture balance, off-loading, reduce bacterial burden and nutritional counseling.

Sponsors & Collaborators

  • Dabir Surfaces Inc

    collaborator INDUSTRY

  • SerenaGroup, Inc.

    lead NETWORK

Principal Investigators

  • Laura Serena · cro

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2023-05-01
Completion
2023-06-30

Countries

  • United States

Study Locations

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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 NCT05033470 on ClinicalTrials.gov