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