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

NCT ID: NCT03107143

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 431 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-15
• Study Completion Date: 2017-05-01

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.

Conditions

Pressure Ulcer, Buttock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Treatment Group

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.

Group Type: EXPERIMENTAL

Q2 System

Intervention Type: DEVICE

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Q2 System

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TurnCare Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jitendra Bharucha, MD

Role: PRINCIPAL_INVESTIGATOR

St. Vincent's Center for Wound Healing

Other Identifiers

16-307

Identifier Type: -

Identifier Source: org_study_id