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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Laura Everson
- E-mail: Laura.Everson@smith-nephew.com
Studijní záloha kontaktů
- Jméno: Jay Dobson
- Telefonní číslo: 206-495-7058
- E-mail: Jay.Dobson@smith-nephew.com
Studijní místa
-
-
Colorado
-
Grand Junction, Colorado, Spojené státy, 81501
- VA Western Colorado Health Care System
-
Kontakt:
- Marty Jacobson
- Telefonní číslo: 2153 910-242-0731
- E-mail: marty.jacobson@va.gov
-
Vrchní vyšetřovatel:
- Eric Hanly, MD
-
-
Georgia
-
Atlanta, Georgia, Spojené státy, 30303
- Grady Memorial Hospital
-
Kontakt:
- Katherine Bachman
- Telefonní číslo: 404-251-0637
- E-mail: katherine.bachman@emory.edu
-
Vrchní vyšetřovatel:
- Laura Johnson, MD
-
-
Indiana
-
Indianapolis, Indiana, Spojené státy, 46202
- Indiana University Health University Hospital
-
Kontakt:
- Heather Adams
- Telefonní číslo: 317-962-1130
- E-mail: hadams3@iuhealth.org
-
Vrchní vyšetřovatel:
- Terrie Beeson, MSN
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: ALLEVYN◊ COMPLETE CARE Sacrum
ALLEVYN◊ COMPLETE CARE Sacrum as preventative measure for hospital-acquired pressure injuries |
ALLEVYN◊ COMPLETE CARE Sacrum foam dressing |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cumulative Incidence of Any Sacral Hospital-Acquired Pressure Injury Through Day 7
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cumulative Incidence of Sacral Hospital-Acquired Pressure Injury: Stage 2-4, Unstageable, and/or Deep Tissue Pressure Injury Through Day 7
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Amanda Spitzer, MBA, RN, Smith & Nephew, Inc.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SNIS-W-1349
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .