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Study of TurnCare's Q-2 System on the Sacral Pressure Ulcer Prevention in High Risk Patients

NCT03107143 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2017-04-11

No results posted yet for this study

Summary

This is a non-blind randomized clinical trial to determine the efficacy of the TurnCare Q2 System for the prevention of sacral region (sacral, coccygeal, and buttocks) pressure ulcers. TurnCare Q2 System has 2 main components: 1. An Inflatable Skin Perfusion Enhancement Surface and 2. An Adaptive Pressure Controller. The Skin Perfusion Enhancement Surface has a patented design that accommodate human anatomy in the sacra region. The Adaptive Pressure Controller is powered by APSAR technology that provides patient specific pressure relieve in the sacral region.

Conditions

  • Pressure Ulcer, Buttock

Interventions

DEVICE

Q2 System

Sponsors & Collaborators

  • TurnCare Inc.

    lead INDUSTRY

Principal Investigators

  • Jitendra Bharucha, MD · St. Vincent's Center for Wound Healing

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-15
Primary Completion
2016-10-31
Completion
2017-05-01
FDA Device
Yes

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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 NCT03107143 on ClinicalTrials.gov