Pressure Redistributing Overlay With Targeted Cooling Technology (PRO-TECT) for Pressure Ulcer Prevention

Objective - To demonstrate the efficacy of the pressure redistributing cooling mattress overlay compared to usual care in mitigating the progression of early pressure ulcers in critically ill (ICU) patients via a prospective randomized human clinical trial.

Specific Aim - The clinical trial will evaluate the efficacy and safety of the PRO-TECT ™ mattress overlay in ICU patients who have already developed early pressure ulcers (Stage 1 and 2) and preventing further progression to more severe pressure ulcers (Stage 3 and 4) as well as potential faster regression (i.e. healing of Stage 1 and 2 pressures).

Study Overview

• Status: Withdrawn
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: PRO-TECT

Detailed Description

To demonstrate the efficacy of the pressure redistributing cooling mattress overlay for prevention of pressure ulcers in critical care units, a prospective randomized human clinical trial will be performed. The trial will use functionally equivalent test overlays. The initial pilot clinical trial will evaluate the efficacy and safety of the PRO-TECT ™ mattress overlay in ICU patients who have already developed early pressure ulcers (Stage 1 and 2) and preventing further progression.

The trial will be performed in UPMC ICUs by enrolling patients age 18 or older with Stage 1 and Stage 2 sacral/coccyx pressure ulcers. The trial will consist of 2 arms: 1) current usual care (UC) vs. 2) UC + targeted cooling overlay mattress (TCOM). Exclusion criteria will include anticipated ICU length of stay < 3 days, patients initially designated for specialty overlay/bed for pulmonary or bariatric diagnoses, patients with a Stage 3 or 4 or unstageable pressure ulcer on the sacrum.

The UC group will receive current UPMC ICU guideline-based care with daily assessments for sacral pressure ulcers. Nursing care guidelines will be applied including frequent patient turning, pressure alleviation, moisture control, and friction relief applications. Patients in this group may receive a specialty bed or overlay mattress without cooling if recommended by wound care specialist. The TCOM group will receive UC plus overlay mattress with targeted sacral cooling.

Wound care as well as assessment will be performed daily by the non-wound care nurses ( ie. ICU nurse while under ICU care and Floor nurses while under non-ICU care) as part of their regular daily assessment for both non-target cooling and targeted cooling patients. Wound care specialist will assess the wound on Mon/Wed/Fri for any progression or deterioration of the wounds. These wound care nurses are specialty trained in stage decubitus as well as recommending changes in care to promote healing. Additionally they will record the data as part of their routine care of patient with wounds. Theses types of wound assessments are best performed every 2-3 days in order to see any significant change of therapy and data will be recorded.

Data collected on Monday, Wednesday and Friday of each week including Braden score, pressure ulcer stage, healing progression (or deterioration) with measurements (e.g., size), and evidence of infection. Additionally, frequency of patient reposition will be recorded and if not, documentation of justification will be provided. Other data collected will include demographics, vitals, comorbidities, length of times (prior incapacitation at home or nursing facility, transport, emergency department, operative room), ventilation and oxygenation requirement, ventilator days, ICU LOS, need for dialysis, vasopressors, and labs including nutritional labs. Data will be collected until study endpoint of discharge from hospital. Final cost analysis will be performed to compile a cost-benefit of each arm. Accrual will be 6 months.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients 18-100 years of age
• Patients with Stage 1 or 2 pressure ulcers

Exclusion Criteria:

• Patients < 18 years old
• Patients admitted directly to non-critical care beds
• Patients with undetermined stage or late stage (3 or 4) pressure ulcers
• Patients with Raynauds disease
• Patients with spina bifida

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care (SOC); Patients receive usual or standard of care regarding management of early stage pressure ulcers
Experimental: SOC plus PRO-TECT; Patients receive usual or standard of care plus the addition of PRO-TECT.	Device: PRO-TECT; Patient will be placed on ROHO SOFFLEX2 mattress with has been modified with gel cushions in the sacral region for heal dissipation by standard closed system cooling pad

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final Pressure Ulcer Stage	Measure of the severity of the pressure ulcer at the time of discharge	at each patient discharged from acute care hospital setting, usually 2-4 weeks

Collaborators and Investigators

• Sponsor: David Brienza
• Investigators: Principal Investigator: David M Brienza, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: December 6, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 18, 2015

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Cooling; Sacral; Overlay Mattress
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: PRO14120116

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No