Pressure Injury Treatment by Intermittent Electrical Stimulation:
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05085288 |
|
Recruitment Status :
Recruiting
First Posted : October 20, 2021
Last Update Posted : April 12, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stage 1 or 2 Sacral or Ischial Pressure Ulcer in the ICU Environment | Device: Intermittent electrical stimulation system (IES) treatment and turning patient every two hours Other: Turning population every two hours | Not Applicable |
This is a two-arm, prospective randomized control trial assessing whether IES combined with the standard of care (treatment) is superior to the standard of care alone (control). The study is a parallel design, adaptive, non-blinded randomized controlled trial, and uses two-sided analysis. We plan interim analyses at each 25% of the maximum N. Part of the early interim analyses (first and second) will involve reassessing the a priori assumptions on data distributions and variability use in sample size calculations and updating the maximum study size needed. Treatment effect results will be shared with the Data Safety Monitoring Board (DSMB) to determine whether the study should be ended early for either futility or having demonstrated superiority of the intervention. Patients can be entered into the protocol multiple times with independent assessments of inclusion/exclusion criteria and new consent for each enrollment. At each enrollment they will be re-randomized to either experimental or control arm. For the purpose of overall survival analysis (the only endpoint with a delayed assessment of outcome), such patients will be excluded.
This trial studies adult inpatients requiring intensive care with either new or established stage 1 or stage 2 sacral and ischial pressure injuries. Patients with a pacemaker/AICD, myasthenia gravis, rhabdomyolysis, gluteal skin breakdown, and unstable fractures at risk of displacement by IES are excluded. Patients with atrial or ventricular wires after cardiac surgery can be enrolled as long as they are not being paced or in the opinion of the treating physician are at high risk of requiring pacing. Prescription of neuromuscular blocking drugs is prohibited except for short term neuromuscular blockade usage for necessary procedures such as intubation or operating room visits.
Subjects will be assessed for pressure injury status from point of randomization to discharge, death, or a minimum of 30 days. Device utilization and data collection will stop after 14 days in a non-ICU environment or when a total of 30 days of data collection has been met. If subjects are in the ICU longer than 30 days or when the combined total of ICU and less than 14 non-ICU days is greater than 30 days, the assessment and use of the device may continue after 30 days. Following entry into the study, participants will receive either the IES device in addition to the standard of care (treatment group) or the standard of care alone (control group). The study is expected to complete accrual within 12-18 months. Participant treatment will occur for the same amount of time as pressure injury assessment occurs as described above
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| Official Title: | The PROTECT 2 Study: Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial |
| Actual Study Start Date : | February 8, 2022 |
| Estimated Primary Completion Date : | June 2024 |
| Estimated Study Completion Date : | January 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Intermittent electrical stimulation system (IES) treatment Group
Charged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10 seconds every 10 minutes.
|
Device: Intermittent electrical stimulation system (IES) treatment and turning patient every two hours
The investigators propose to assess whether addition of the IES system and the use of the standard of care procedure of turning the patient every two hours reduces the morbidity of sacral and ischial pressure injuries by decreasing progression of stage 1 or stage 2 ulcers or facilitates their healing compared to standard wound care in an inpatient critical care population. |
|
Active Comparator: Standard of care Group
Turning the patient every two hours as per standard inpatient nursing practice and any other wound care or plastic surgery treatments deemed appropriate as per usual care.
|
Other: Turning population every two hours
The investigators propose to assess whether standard of care of turning the patient every two hours reduces the morbidity of sacral and ischial pressure injuries. |
- Efficacy of adding the IES System to standard of care [ Time Frame: 24 hours of admission to the ICU ]Investigators will assess the IES System to determine the efficacy of an IES system after being added to the standard of care of turning patients every two hours on the primary outcome of sacral and ischial pressure injury score measured over time.
- Compare using the IES oppose to only standard care [ Time Frame: 24 hours of admission to the ICU ]Investigators will assess time to resolution of the ulcer
- Compare IES to standard care [ Time Frame: 24 hours of admission to the ICU ]Time to resolution of ulcer
- Evaluate treatment effect heterogeneity across levels of the following patient factors [ Time Frame: 24 hours of admission to the ICF until discharged ]By the measurement of Ulcer stage at enrollment (Stage 1 or Stage 2)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Either new or established stage 1 or 2 sacral or ischial pressure ulcer in the ICU environment.
- Participants capable of giving informed consent, or if propitiate, participants having an acceptable individual capable of giving consent on the participant's behalf.
Exclusion Criteria:
- Existing pressure injuries above Stage II and injuries classified as DTI or unstageable
- Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction.
- Rhabdomyolysis
- Presence of permanent pacemaker or AICD, and for those with external wires after cardiac surgery, those who are using or at high risk for the development of a requirement for an external pacemaker.
- Skin breakdown or malignant skin involvement over the gluteal regions that would preclude the use of surface electrodes.
- BMI > 40
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085288
| Contact: Roberta Johnson | 216-444-9950 | johnsor13@gmail.com | |
| Contact: Fabio Rodriguez, MD | 216-444-9674 | RODRIGF3@ccf.org |
| United States, North Carolina | |
| Wake Forest Unverisity | Recruiting |
| Winston-Salem, North Carolina, United States, 27109 | |
| Contact: Lynne Harris 336-306-0778 lcharris@wakehealth.edu | |
| Contact: Ashish Khanna, MD ashish9805@icloud.com | |
| Principal Investigator: Ashish Khanna, MD | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org | |
| Austria | |
| Univeristy of Graz | Recruiting |
| Graz, Austria, A-8010 | |
| Principal Investigator: | Chase Donaldson, MD | The Cleveland Clinic | |
| Study Chair: | Andrea Kurz, MD | The Cleveland Clinic |
| Responsible Party: | The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT05085288 |
| Other Study ID Numbers: |
21-1009 - The PROTECT 2 ICU |
| First Posted: | October 20, 2021 Key Record Dates |
| Last Update Posted: | April 12, 2023 |
| Last Verified: | April 2023 |
| 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 |
|
Pressure Ulcer Crush Injuries Skin Ulcer Skin Diseases Wounds and Injuries |