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

Primary Purpose

Pressure Ulcer, Buttock

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Q2 System
Sponsored by
TurnCare Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer, Buttock focused on measuring Pressure ulcer prevention, Pressure injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects have a Braden Score of 16 or less without pre-existing sacral region pressure ulcers and are not subject to exclusion criteria

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment Group

    Control Group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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."

    Secondary Outcome Measures

    Full Information

    First Posted
    March 30, 2017
    Last Updated
    April 4, 2017
    Sponsor
    TurnCare Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03107143
    Brief Title
    Study of TurnCare's Q-2 System on the Sacral Pressure Ulcer Prevention in High Risk Patients
    Official Title
    A Randomized, Non-blind Study of TurnCare's Q-2 System on the Sacral Pressure Ulcer Prevention in High Risk Patients at St. Vincent's Medical Center
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 15, 2016 (Actual)
    Primary Completion Date
    October 31, 2016 (Actual)
    Study Completion Date
    May 1, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    TurnCare Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    This study is a prospective, non-blinded randomized clinical trial. The study protocol and the consent form were approved by the IRB at the study institution. Consecutive adult patients admitted to the hospital with Braden Scale scores of 16 or less who did not meet exclusion criteria were consented and enrolled in the study. All in-patients were either scheduled admissions or were admitted through the emergency department. Upon admission, risk assessments for pressure ulcers and total body surveys were performed by the hospital staff. A Braden Scale score was determined for each patient by the hospital staff according to standard hospital protocol. Both the control group and the treatment group patients received standard care for pressure ulcer prevention according to hospital protocols, policies and guidelines. Standard pressure ulcer prevention measures for this facility include a methodology referred to as a "S.K.I.N." Bundle (S-surface selection, K-keep turning, I-incontinence management, N-nutrition.) This successful pressure ulcer prevention initiative was developed within the parent health organization and standardized throughout its 131 hospitals. In accordance with the S.K.I.N. Bundle, all patients admitted to the study hospital were repositioned every two hours, provided incontinence care, and given aggressive nutritional management as indicated. All care measures were documented in the hospital's electronic medical record (EMR) system. After obtaining informed consents, patients in the treatment group had the Q2 System placed on their beds and chairs. Perfusion enhancement surfaces were placed directly on hospital beds under the fitted bed sheets and were secured to bed frames with disposable Velcro straps. A disposable "chux" pad and lifter sheet were placed on top of the fitted sheets as is standard in most hospital settings. Adaptive pressure controllers were secured to bed footboards or attached to bases of IV poles. Specific settings for each patient were entered into the controllers. The controller settings entered included patient body weight and bed position (degrees of incline). The bed position included a bed setting (30 degrees incline) and a chair setting (90 degrees incline). When applicable, a second perfusion enhancement surface was placed on a hospital chair so that the Q2 solution could be utilized in a "sitting mode" while patients were sitting in hospital chairs. The Q2 Systems remained in continuous operation during the trial period. Patient skin did not contact any part of the Q2 system directly at any time.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pressure Ulcer, Buttock
    Keywords
    Pressure ulcer prevention, Pressure injury

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A prospective, non-blinded, randomized trial. This cohort was divided into two groups: Control and Treatment.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    431 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Control subjects receive only standard care of pressure ulcer prevention according to study hospital's policy and protocol without Q2 System
    Intervention Type
    Device
    Intervention Name(s)
    Q2 System
    Primary Outcome Measure Information:
    Title
    Incidence of hospital acquired sacral region pressure ulcers in treatment and control groups.
    Description
    Rate of hospital acquired sacral pressure ulcer occurrence measurred in metrics named "number of incidences in 1,000 patient days."
    Time Frame
    Up to 10 weeks. Average of 4 weeks from enrollment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects have a Braden Score of 16 or less without pre-existing sacral region pressure ulcers and are not subject to exclusion criteria Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jitendra Bharucha, MD
    Organizational Affiliation
    St. Vincent's Center for Wound Healing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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