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Effect of a Risk-Based Perioperative Pressure Injury Prevention Bundle in Elective Surgery Patients (RiPPB)

2026年7月21日 更新者：Acibadem University

Effect of a Risk-Based Perioperative Pressure Injury Prevention Bundle on Pressure Injury Development in Patients Undergoing Elective Surgery: A Randomized Controlled Trial

This study evaluates whether a risk-based perioperative pressure injury prevention bundle reduces the development of pressure injuries in patients undergoing elective surgery lasting 3 hours or longer.

Pressure injuries that develop during and after surgery are a common patient safety problem, especially in older adults and in longer procedures. In this randomized controlled trial, patients will be assigned by chance to either an intervention group or a control group. In the intervention group, each patient's pressure injury risk will be assessed before surgery using the Braden Scale together with additional perioperative risk factors, and patients will then receive one of three prevention bundles matched to their risk level (low, moderate, or high). The high-risk bundle includes prophylactic silicone foam dressings on the sacrum and heels, targeted positioning, and pressure-redistributing support surfaces. The control group will receive standard perioperative care without risk-based bundling, although Braden Scale assessment will still be performed.

Skin assessments will be conducted at four time points: before surgery, in the post-anesthesia care unit, at 2-4 hours after surgery, and at 24 hours after surgery. The main outcome is whether patients develop early signs of pressure injury, including non-blanchable erythema, within the first 24 postoperative hours. The study hypothesizes that patients receiving the risk-based prevention bundle will have a lower incidence of postoperative pressure injury and non-blanchable erythema compared with patients receiving standard care.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

This is a prospective, two-arm, parallel-group randomized controlled trial conducted according to the CONSORT 2025 guideline. Participants will be enrolled from orthopedic, general surgery, urology, and neurosurgery services at a single center. Block randomization with concealed allocation (sealed envelopes) will be used to assign participants to the intervention or control arm in a 1:1 ratio.

In the intervention arm, risk stratification will be based on the Braden Scale score combined with additional perioperative risk factors (e.g., surgical duration, ASA class, intraoperative hypotension or hypothermia, surgical position). Patients will be categorized into low-, moderate-, or high-risk subgroups, each receiving a distinct prevention bundle consisting of positioning strategies, support-surface selection, and, for high-risk patients, prophylactic silicone foam dressings.

Data will be collected using a study-specific instrument developed based on the 2025 EPUAP/NPIAP/PPPIA Pressure Injury Prevention Guideline, consisting of a demographic/clinical data section, the Braden Scale, a bundle-implementation checklist (intervention arm only), and a skin assessment outcome form completed at all four time points for both arms. Data will be analyzed using SPSS, with chi-square tests for categorical variables, independent-samples t-tests for continuous variables, and logistic regression to control for potential confounding by Braden score.

研究の種類

介入

入学 (推定)

138

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • Scheduled to undergo elective orthopedic, general, neurosurgical, or urological surgery
  • Anticipated surgical duration greater than 3 hours
  • No pressure injury present preoperatively
  • Willing and able to provide informed consent to participate

Exclusion Criteria:

  • Existing pressure injury at enrollment
  • Undergoing emergency surgery
  • Known allergy to dressing/adhesive materials used in the prevention bundle
  • Severe dermatological condition affecting skin integrity
  • Unplanned postoperative intensive care unit admission

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：ランダム化
  • 介入モデル：並列代入
  • 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：Risk-Based Prevention Bundle
Participants receive a risk-based perioperative pressure injury prevention bundle. Based on Braden Scale score and additional perioperative risk factors, participants are categorized as low, moderate, or high risk and receive the corresponding bundle: low risk (routine positioning, standard support surface, standard skin assessment), moderate risk (targeted padding/off-loading, support surface optimization, detailed skin assessment), or high risk (prophylactic silicone foam dressings on sacrum and heels, targeted positioning, pressure-redistributing support surfaces, detailed skin assessment in PACU and at 2-4 hours postoperative).
他の：Risk-Based Perioperative Pressure Injury Prevention Bundle
A three-tier prevention bundle (low, moderate, high risk), tailored to each patient's Braden Scale score combined with additional perioperative risk factors. The high-risk tier includes prophylactic silicone foam dressings applied to the sacrum and heels, targeted intraoperative positioning, and pressure-redistributing support surfaces; the moderate-risk tier includes targeted padding/off-loading and support-surface optimization; the low-risk tier includes routine positioning and standard support-surface use. Skin assessment is conducted at four perioperative time points.
他の名前：
  • RiPPB
介入なし：Standard Perioperative Care
Participants receive the institution's existing standard perioperative care without risk-based bundling. The Braden Scale is still administered for data purposes, but risk classification does not guide any additional preventive intervention. Skin assessment is performed at the same time points as the intervention arm (preoperative, PACU, 2-4 hours postoperative, and 24 hours postoperative).

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
Incidence of Postoperative Pressure Injury
時間枠：Assessed at 24 hours after surgery (T3)
Development of a pressure injury (including non-blanchable erythema) at any assessed anatomical site (sacrum, right/left heel, occiput, scapula, elbow, right/left trochanter, right/left malleolus, or other site), assessed via skin examination and recorded as Yes/No.
Assessed at 24 hours after surgery (T3)

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Anatomical Sites at Risk
時間枠：Assessed at 24 hours after surgery (T3)
Count of anatomical sites (sacrum, heels, occiput, scapula, elbows, trochanters, malleoli, and other sites) showing signs of pressure injury or non-blanchable erythema per participant.
Assessed at 24 hours after surgery (T3)
Protocol Adherence
時間枠：Assessed throughout the perioperative period, from preoperative (T0) through 24 hours postoperative (T3)
Proportion of prevention bundle components (positioning, support surface use, prophylactic dressing application) delivered as specified for each risk-level tier in the intervention arm, recorded as Yes/No for each component.
Assessed throughout the perioperative period, from preoperative (T0) through 24 hours postoperative (T3)
Incidence of Non-Blanchable Erythema
時間枠：Assessed preoperatively (T0), in the post-anesthesia care unit (T1), at 2-4 hours postoperative (T2), and at 24 hours postoperative (T3)
Presence of non-blanchable erythema (early sign of pressure injury) at any assessed anatomical site, recorded as Yes/No.
Assessed preoperatively (T0), in the post-anesthesia care unit (T1), at 2-4 hours postoperative (T2), and at 24 hours postoperative (T3)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Acibadem University

捜査官

  • スタディディレクター：Ayper Önal Alkan, RN, PhD,、Acıbadem Mehmet Ali Aydınlar University
  • 主任研究者：Ukke Karabacak, Professor、Acıbadem Mehmet Ali Aydınlar University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2026年12月12日

研究の完了 (推定)

2026年12月30日

試験登録日

最初に提出

2026年7月21日

QC基準を満たした最初の提出物

2026年7月21日

最初の投稿 (実際)

2026年7月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月24日

QC基準を満たした最後の更新が送信されました

2026年7月21日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • ATADEK-2026/07

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?

いいえ

IPD プランの説明

Individual participant data will not be made publicly available due to institutional data protection policies and the absence of a current data-sharing agreement. De-identified data may be made available upon reasonable request to the corresponding author, subject to institutional approval.

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