Sacrum Pressure Injury Prevention Study Using ALLEVYN◊ Complete Care in Adults at Risk of Developing Hospital-acquired Pressure Injuries in Critical Care Units (PACCT)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Laura Everson
- E-mail: Laura.Everson@smith-nephew.com
Studie Contact Back-up
- Naam: Jay Dobson
- Telefoonnummer: 206-495-7058
- E-mail: Jay.Dobson@smith-nephew.com
Studie Locaties
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Colorado
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Grand Junction, Colorado, Verenigde Staten, 81501
- VA Western Colorado Health Care System
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Contact:
- Marty Jacobson
- Telefoonnummer: 2153 910-242-0731
- E-mail: marty.jacobson@va.gov
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Hoofdonderzoeker:
- Eric Hanly, MD
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30303
- Grady Memorial Hospital
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Contact:
- Katherine Bachman
- Telefoonnummer: 404-251-0637
- E-mail: katherine.bachman@emory.edu
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Hoofdonderzoeker:
- Laura Johnson, MD
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46202
- Indiana University Health University Hospital
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Contact:
- Heather Adams
- Telefoonnummer: 317-962-1130
- E-mail: hadams3@iuhealth.org
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Hoofdonderzoeker:
- Terrie Beeson, MSN
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: ALLEVYN◊ COMPLETE CARE Sacrum
ALLEVYN◊ COMPLETE CARE Sacrum as preventative measure for hospital-acquired pressure injuries |
ALLEVYN◊ COMPLETE CARE Sacrum foam dressing |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cumulative Incidence of Any Sacral Hospital-Acquired Pressure Injury Through Day 7
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cumulative Incidence of Sacral Hospital-Acquired Pressure Injury: Stage 2-4, Unstageable, and/or Deep Tissue Pressure Injury Through Day 7
Tijdsspanne: 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
Tijdsspanne: 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:
|
Day 0 to Day 7
|
|
Number of Days to Clinical Diagnosis of Sacral Hospital-Acquired Pressure Injury (HAPI)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Amanda Spitzer, MBA, RN, Smith & Nephew, Inc.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SNIS-W-1349
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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