Sacrum Pressure Injury Prevention Study Using ALLEVYN◊ Complete Care in Adults at Risk of Developing Hospital-acquired Pressure Injuries in Critical Care Units (PACCT)

September 24, 2026 updated by: Smith & Nephew, Inc.

An Evaluation of Hospital-Acquired Pressure Injury Prevention Using ALLEVYN COMPLETE CARE Sacrum Foam Dressing - A Prospective, Single-Arm Trial (Project Name - PACCT)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hospital-acquired pressure injuries (also known as pressure ulcers or bed sores) remain a common issue for patients confined to beds in hospitals. This study will see whether the use of a particular foam dressing (ALLEVYN◊ COMPLETE CARE Sacrum) in combination with standard pressure injury prevention protocols will reduce pressure injuries development compared to known rates of pressure injuries for adults receiving critical or intermediate hospital care. Participants will have the study dressing applied to the lower back/tailbone area, in addition to hospital standard methods used, to try to prevent pressure injuries. Study participation will last up to 14 days. Additional assessments will evaluate the severity and timing of any pressure injuries that occur, dressing utilization, clinician satisfaction with the dressing, dressing wear characteristics, health economic outcomes, and the relationship between pressure injury occurrence, skin tone and other risk factors.

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • VA Western Colorado Health Care System
        • Contact:
        • Principal Investigator:
          • Eric Hanly, MD
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Laura Johnson, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health University Hospital
        • Contact:
        • Principal Investigator:
          • Terrie Beeson, MSN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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's Braden Scale score is ≤18 at time of screening
  • Subject is recruited within 18 hours of arrival to hospital (Emergency Department, perioperative area or Critical or Intermediate Care Units)
  • Subjects' life expectancy is ≥3 days (as assessed by clinical judgment within 24 hours of consent)
  • Subjects expected Critical and/or Intermediate Care stay is ≥3 days (clinical judgment)

Exclusion Criteria:

  • 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)
  • Subject has a medical condition or orders that, in the opinion of the Investigator, prevent repositioning (e.g., hemodynamic instability or unstable spine) or positioning which would exclude the supine position (e.g., prone positioning) (clinical judgment)
  • Subjects with orders for, or expected to receive orders for, prone positioning (clinical judgment)
  • Known extended period, prior to enrolment, without documented repositioning in the opinion of the Investigator. e.g., Subject has had ≥6 hours of known pressure on the sacral area, subject found down, extended operating time etc.
  • Subject is currently receiving end-of-life care or comfort care only
  • Subject has existing sacral skin injury or has irregular skin features (e.g., tattoos, pre-existing scarring, evidence of prior healed pressure injury, unusual anatomy such as dimples or bony prominences) which in the opinion of the Investigator, will interfere with the study assessments.
  • Subject has uncontrolled/unmitigated urinary and/or fecal incontinence (e.g., controlled defined as incontinence reasonably managed through the use of a device such as indwelling catheter, fecal management system, external urinary catheter, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALLEVYN◊ COMPLETE CARE Sacrum

ALLEVYN◊ COMPLETE CARE Sacrum as preventative measure for hospital-acquired pressure injuries
Device: ALLEVYN◊ COMPLETE CARE Sacrum

ALLEVYN◊ COMPLETE CARE Sacrum foam dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Incidence of Any Sacral Hospital-Acquired Pressure Injury Through Day 7
Time Frame: Day 0 to 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.
Day 0 to Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Incidence of Sacral Hospital-Acquired Pressure Injury: Stage 2-4, Unstageable, and/or Deep Tissue Pressure Injury Through Day 7
Time Frame: Day 0 to 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.
Day 0 to Day 7
Cumulative Incidence of Each Sacral Hospital-Acquired Pressure Injury: Stage 1-4, Unstageable, and/or Deep Tissue Pressure Injury Through Day 7
Time Frame: Day 0 to 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
Day 0 to Day 7
Number of Days to Clinical Diagnosis of Sacral Hospital-Acquired Pressure Injury (HAPI)
Time Frame: Day 0 to Day 14

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.
Day 0 to Day 14
Dressing Utilization
Time Frame: Day 0 to Day 14

Dressing utilization will be summarized by the number of dressing changes throughout the treatment period, approximately 14 days.
Day 0 to Day 14
Dressing Wear Time
Time Frame: Day 0 to Day 14

The duration of study dressing wear will be summarized as the total number of days the study dressing was worn during each 7-day period.
Day 0 to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Study Chair: Amanda Spitzer, MBA, RN, Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

October 24, 2028

Study Completion (Estimated)

November 7, 2028

Study Registration Dates

First Submitted

September 24, 2026

First Submitted That Met QC Criteria

September 24, 2026

First Posted (Actual)

September 30, 2026

Study Record Updates

Last Update Posted (Actual)

September 30, 2026

Last Update Submitted That Met QC Criteria

September 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNIS-W-1349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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