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

NCT03107143 | Unknown DMC FDA Device

• 1 other identifier: 16-307
• Study Type: interventional
• Target: 431
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Pressure ulcer prevention; Pressure injury

Outcome Measures

Primary Outcomes (1)

• Incidence of hospital acquired sacral region pressure ulcers in treatment and control groups.

  Rate of hospital acquired sacral pressure ulcer occurrence measurred in metrics named "number of incidences in 1,000 patient days."

  Up to 10 weeks. Average of 4 weeks from enrollment.

Study Arms (2)

Treatment Group

EXPERIMENTAL

Trial subjects have Q2 System installed on their beds in addition to receiving standard care of pressure ulcer prevention according to study hospital's policy and protocol.

Device: Q2 System

Control Group

NO INTERVENTION

Control subjects receive only standard care of pressure ulcer prevention according to study hospital's policy and protocol without Q2 System

Interventions

Q2 System DEVICE

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pre-existing sacral region pressure ulcer
• Refusal to participate
• Inability to obtain consent
• Pregnancy
• Age less than 18 years
• Mentally challenged
• Prisoner
• Unstable spine or pelvic injuries
• Recent surgical skin graft to sacral area
• Weight \> 400 lbs.
• Psychiatric condition

Sponsors & Collaborators

• TurnCare Inc.: lead

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jitendra Bharucha, MD

  St. Vincent's Center for Wound Healing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, non-blinded, randomized trial. This cohort was divided into two groups: Control and Treatment.

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 11, 2017
• Study Start: June 15, 2016
• Primary Completion: October 31, 2016
• Study Completion: May 1, 2017
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share