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

NCT02634892 | Withdrawn FDA Device

• 1 other identifier: PRO14120116
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pressure Ulcer

Keywords

Sacral; Overlay Mattress; Cooling

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of Care (SOC)

NO INTERVENTION

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

SOC plus PRO-TECT

EXPERIMENTAL

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

Device: PRO-TECT

Interventions

PRO-TECT 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

SOC plus PRO-TECT

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Brienza: lead

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David M Brienza, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2015
• First Posted: December 18, 2015
• Study Start: July 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07