Pressure Ulcers (Hospital-acquired Pressure Injuries)PACCTNCT07849387
Sacrum Pressure Injury Prevention Study Using ALLEVYN◊ Complete Care in Adults at Risk of Developing Hospital-acquired Pressure Injuries in Critical Care Units
A study testing ALLEVYN◊ COMPLETE CARE Sacrum in people with Pressure Ulcers (Hospital-acquired Pressure Injuries), run by Smith & Nephew, Inc. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers (Hospital-acquired Pressure Injuries)
- What is being tested?
- ALLEVYN◊ COMPLETE CARE Sacrum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Oct 2026to 7 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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.)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Everson contact
United States3 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Katherine Bachman, 404-251-0637, katherine.bachman@emory.edu
Laura Johnson, MD
VA Western Colorado Health Care System
Grand Junction, Colorado, 81501
Marty Jacobson, 910-242-0731 ext. 2153, marty.jacobson@va.gov
Eric Hanly, MD
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Heather Adams, 317-962-1130, hadams3@iuhealth.org
Terrie Beeson, MSN
About this study
Official title: 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.
Read the 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.
- Being tested
- ALLEVYN◊ COMPLETE CARE Sacrum
- Keywords
- Pressure injury prevention, Hospital-acquired pressure injury
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLEVYN◊ COMPLETE CARE SacrumDevice
ALLEVYN◊ COMPLETE CARE Sacrum foam dressing
| Study group | Role | What they receive |
|---|---|---|
| ALLEVYN◊ COMPLETE CARE Sacrum | Experimental | ALLEVYN◊ COMPLETE CARE Sacrum as preventative measure for hospital-acquired pressure injuries Receives: Device: ALLEVYN◊ COMPLETE CARE Sacrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 to Day 7
Secondary outcomes (5)
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.
Measured: 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
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
Measured: Day 0 to Day 7
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.
Measured: Day 0 to Day 14
Dressing Utilization
Dressing utilization will be summarized by the number of dressing changes throughout the treatment period, approximately 14 days.
Measured: Day 0 to Day 14
Dressing Wear Time
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.
Measured: Day 0 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion24 Oct 2028 (estimated)
- Study completion7 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcers (Hospital-acquired Pressure Injuries)Studies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amanda Spitzer, MBA, RN, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849387
- Sponsor's protocol ID
- SNIS-W-1349
- Acronym
- PACCT
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Hospital-Acquired Pressure Injury Prevention Using ALLEVYN COMPLETE CARE Sacrum Foam Dressing - A Prospective, Single-Arm Trial (Project Name - PACCT)
- ClinicalTrials.gov ID
- NCT07849387
- Acronym / sponsor ID
- PACCT / SNIS-W-1349
- Keywords
- Pressure injury prevention, Hospital-acquired pressure injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 24 Oct 2028 (estimated)
- Study completion
- 7 Nov 2028 (estimated)
- First posted
- 30 Sep 2026 (actual)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALLEVYN◊ COMPLETE CARE Sacrum | Experimental | Device: ALLEVYN◊ COMPLETE CARE SacrumALLEVYN◊ COMPLETE CARE Sacrum as preventative measure for hospital-acquired pressure injuries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| ALLEVYN◊ COMPLETE CARE SacrumALLEVYN◊ COMPLETE CARE Sacrum foam dressing | Device | ALLEVYN◊ COMPLETE CARE Sacrum |
Primary outcome
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.
5 secondary outcomes
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
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
Number of Days to Clinical Diagnosis of Sacral Hospital-Acquired Pressure Injury (HAPI)
Time frame: Day 0 to Day 14
Dressing Utilization
Time frame: Day 0 to Day 14
Dressing Wear Time
Time frame: Day 0 to Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Pressure Ulcers (Hospital-acquired Pressure Injuries)
Not yet recruiting
Impact of Nurses' Behavior Change and Evidence-Based Practice Implementation on Quality Indicators in Intensive Care Units in Low- and Middle-Income Countries
Ventilator-Associated Pneumonia (VAP), Central Line-Associated Bloodstream Infection
Not yet recruiting
Development of a Nursing Care Bundle to Prevent Pressure Injuries and Its Impact on Rates and Costs
Pressure Injury, Hospital Acquired Pressure Ulcer
Not yet recruiting
IDEAL SKIIN CARES Bundle to Prevent Pressure Injury
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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.
Laura Everson contact
Amanda Spitzer, MBA, RN study chair
Smith & Nephew, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALLEVYN◊ COMPLETE CARE Sacrum in people with Pressure Ulcers (Hospital-acquired Pressure Injuries), run by Smith & Nephew, Inc. at 3 sites in United States.
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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Dobson (206-495-7058, Jay.Dobson@smith-nephew.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Any Sacral Hospital-Acquired Pressure Injury Through Day 7 (time frame: Day 0 to Day 7). 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 30 Sep 2026.