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

NCT ID: NCT02634892

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2019-07-01

Brief Summary

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).

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.

Conditions

Pressure Ulcer

Study Design

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

Study Groups

Standard of Care (SOC)

Patients receive usual or standard of care regarding management of early stage pressure ulcers

Group Type: NO_INTERVENTION

No interventions assigned to this group

SOC plus PRO-TECT

Patients receive usual or standard of care plus the addition of PRO-TECT.

Group Type: EXPERIMENTAL

PRO-TECT

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

David Brienza

OTHER

Sponsor Role: lead

Responsible Party

David Brienza

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David M Brienza, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Other Identifiers

PRO14120116

Identifier Type: -

Identifier Source: org_study_id