The purpose of this study is to investigate the use of ALLEVYN◊ COMPLETE CARE Sacrum dressing for the prevention of hospital-acquired pressure injuries in adults. The main question it aims to answer is whether or not the dressing will prevent pressure injury prevention between application and Day 7. Participants will apply a dressing to the lower back/tailbone area as part of their regular care up to 14 days and participate in ongoing checkups by the study team.
Subject or legally authorized representative (LAR) provides written informed consent
Adults (≥18 years) at time of consent
Willing and able to complete all required study visits
Subjects admitted to Critical Care Units or Intermediate Care Units (may also be called step-down, progressive care, or high dependency units). Subjects may be identified in perioperative or emergency departments before moving to the appropriate unit.
Subject has participated previously in this clinical trial
Subject is currently participating in or has participated in a clinical trial within thirty (30) calendar days of day 0 which could impact the scientific integrity of the study
Subject has a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study.
Subject has a known sensitivity/allergy to dressing and/or adhesive components (e.g., sensitivity to silicone)
Single group
ALLEVYN◊ COMPLETE CARE Sacrum
DeviceALLEVYN◊ COMPLETE CARE Sacrum foam dressing
Cumulative Incidence of Any Sacral Hospital-Acquired Pressure Injury Through Day 7
The cumulative incidence of sacral hospital-acquired pressure injury (HAPI) is defined as the proportion of participants who developed any qualifying sacral HAPI up to and including Day 7 of study dressing application. A sacral skin assessment will be performed to determine whether any sacral HAPI has developed. "Yes" indicates detection of a sacral HAPI classified as Stage 1, Stage 2, Stage 3, Stage 4, unstageable pressure injury, or deep tissue pressure injury. "No" indicates the participant did not develop sacral HAPI by Day 7 or discontinued the study before Day 7 without developing sacral HAPI and was therefore considered event-free. Fewer pressure injuries indicate a better outcome.
Cumulative Incidence of Sacral Hospital-Acquired Pressure Injury: Stage 2-4, Unstageable, and/or Deep Tissue Pressure Injury Through Day 7
The cumulative incidence of sacral hospital-acquired pressure injury (HAPI) is defined as the proportion of participants who developed a stage 2-4, unstageable, or deep tissue HAPI up to and including Day 7 of study dressing application. A sacral skin assessment will be performed to determine whether a qualifying sacral HAPI developed. "Yes" indicates detection of a sacral HAPI classified as Stage 2, Stage 3, Stage 4, unstageable pressure injury, or deep tissue pressure injury. "No" indicates the participant did not develop a qualifying sacral HAPI by Day 7 or discontinued the study before Day 7 without developing a qualifying sacral HAPI and was therefore considered event-free. Fewer pressure injuries indicate a better outcome.
Cumulative Incidence of Each Sacral Hospital-Acquired Pressure Injury: Stage 1-4, Unstageable, and/or Deep Tissue Pressure Injury Through Day 7
The cumulative incidence of sacral hospital-acquired pressure injury (HAPI) defined as the proportion of participants who developed stage 1-4, unstageable, or deep tissue HAPI up to and including Day 7 of study dressing application. A sacral skin assessment will be performed to determine whether a qualifying sacral HAPI developed. The sacral skin assessment will be categorized as one of the following: * Stage 1: Non-blanchable erythema of intact skin Intact skin * Stage 2: Partial-thickness skin loss with exposed dermis * Stage 3: Full-thickness skin loss in which adipose (fat) is visible * Stage 4: Full-thickness skin and tissue loss * Unstageable: Obscured full-thickness skin and tissue loss * Deep Tissue: Intact or non-intact skin with localized area of persistent non-blanchable deep red, maroon or purple discoloration
Number of Days to Clinical Diagnosis of Sacral Hospital-Acquired Pressure Injury (HAPI)
For participants that develop a sacral hospital-acquired pressure injury (HAPI), the number of days from study dressing application on Day 0 to the clinical diagnosis of sacral HAPI will be summarized.
Dressing Utilization
Dressing utilization will be summarized by the number of dressing changes throughout the treatment period, approximately 14 days.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
