Pressure UlcerNCT02634892
Pressure Redistributing Overlay With Targeted Cooling Technology (PRO-TECT) for Pressure Ulcer Prevention
A study testing PRO-TECT in people with Pressure Ulcer, run by David Brienza.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- PRO-TECT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18-100 years of age
- Patients with Stage 1 or 2 pressure ulcers
Who cannot join
- 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
About this study
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).
Read the 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
- Being tested
- PRO-TECT
- Keywords
- Sacral, Overlay Mattress, Cooling
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-TECTDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PRO-TECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final Pressure Ulcer Stage
Measure of the severity of the pressure ulcer at the time of discharge
Measured: at each patient discharged from acute care hospital setting, usually 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study start1 Jul 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Brienza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Brienza, University of Pittsburgh
- Investigators
- David M Brienza, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634892
- Sponsor's protocol ID
- PRO14120116
- Status last verified
- Jul 2019
- First submitted
- 6 Dec 2015
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Redistributing Overlay With Targeted Cooling Technology (PRO-TECT) for Pressure Ulcer Prevention
- ClinicalTrials.gov ID
- NCT02634892
- Acronym / sponsor ID
- PRO14120116
- Conditions
- Pressure Ulcer
- Keywords
- Sacral, Overlay Mattress, Cooling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- David BrienzaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: PRO-TECTPatients receive usual or standard of care plus the addition of PRO-TECT. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18-100 years of age
- Patients with Stage 1 or 2 pressure ulcers
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO-TECTPatient 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 | Device | SOC plus PRO-TECT |
Primary outcome
Final Pressure Ulcer Stage
Time frame: at each patient discharged from acute care hospital setting, usually 2-4 weeks
Measure of the severity of the pressure ulcer at the time of discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
Related trials for Pressure Ulcer
RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
Not yet recruitingObservational study
Explainable AI for Prospective Pressure Injury Staging
Pressure Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Brienza, PhD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing PRO-TECT in people with Pressure Ulcer, run by David Brienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final Pressure Ulcer Stage (time frame: at each patient discharged from acute care hospital setting, usually 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.