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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Laura Everson
- メール：Laura.Everson@smith-nephew.com
研究連絡先のバックアップ
- 名前：Jay Dobson
- 電話番号：206-495-7058
- メール：Jay.Dobson@smith-nephew.com
研究場所
-
-
Colorado
-
Grand Junction、Colorado、アメリカ、81501
- VA Western Colorado Health Care System
-
コンタクト：
- Marty Jacobson
- 電話番号：2153 910-242-0731
- メール：marty.jacobson@va.gov
-
主任研究者：
- Eric Hanly, MD
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30303
- Grady Memorial Hospital
-
コンタクト：
- Katherine Bachman
- 電話番号：404-251-0637
- メール：katherine.bachman@emory.edu
-
主任研究者：
- Laura Johnson, MD
-
-
Indiana
-
Indianapolis、Indiana、アメリカ、46202
- Indiana University Health University Hospital
-
コンタクト：
- Heather Adams
- 電話番号：317-962-1130
- メール：hadams3@iuhealth.org
-
主任研究者：
- Terrie Beeson, MSN
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：ALLEVYN◊ COMPLETE CARE Sacrum
ALLEVYN◊ COMPLETE CARE Sacrum as preventative measure for hospital-acquired pressure injuries |
ALLEVYN◊ COMPLETE CARE Sacrum foam dressing |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cumulative Incidence of Any Sacral Hospital-Acquired Pressure Injury Through Day 7
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cumulative Incidence of Sacral Hospital-Acquired Pressure Injury: Stage 2-4, Unstageable, and/or Deep Tissue Pressure Injury Through Day 7
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Amanda Spitzer, MBA, RN、Smith & Nephew, Inc.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SNIS-W-1349
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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