Effect of a Risk-Based Perioperative Pressure Injury Prevention Bundle in Elective Surgery Patients (RiPPB)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hilal Y Çelik, Lecturer, PhD
- 전화번호: +90 02165004172
- 이메일: hilal.yildiz@acibadem.edu.tr
연구 장소
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Istanbul, 터키 (Türkiye)
- Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi
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연락하다:
- Ayper Önal Alkan, RN, PhD
- 전화번호: +90-533-684-94-74
- 이메일: ayper.alkan@live.acibadem.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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).
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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.
다른 이름들:
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간섭 없음: 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).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence of Postoperative Pressure Injury
기간: Assessed at 24 hours after surgery (T3)
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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.
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Assessed at 24 hours after surgery (T3)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Anatomical Sites at Risk
기간: Assessed at 24 hours after surgery (T3)
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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.
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Assessed at 24 hours after surgery (T3)
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Protocol Adherence
기간: Assessed throughout the perioperative period, from preoperative (T0) through 24 hours postoperative (T3)
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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.
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Assessed throughout the perioperative period, from preoperative (T0) through 24 hours postoperative (T3)
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Incidence of Non-Blanchable Erythema
기간: Assessed preoperatively (T0), in the post-anesthesia care unit (T1), at 2-4 hours postoperative (T2), and at 24 hours postoperative (T3)
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Presence of non-blanchable erythema (early sign of pressure injury) at any assessed anatomical site, recorded as Yes/No.
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Assessed preoperatively (T0), in the post-anesthesia care unit (T1), at 2-4 hours postoperative (T2), and at 24 hours postoperative (T3)
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공동 작업자 및 조사자
수사관
- 연구 책임자: Ayper Önal Alkan, RN, PhD,, Acıbadem Mehmet Ali Aydınlar University
- 수석 연구원: Ukke Karabacak, Professor, Acıbadem Mehmet Ali Aydınlar University
간행물 및 유용한 링크
일반 간행물
- Bulfone G, Bressan V, Morandini A, Stevanin S. Perioperative Pressure Injuries: A Systematic Literature Review. Adv Skin Wound Care. 2018 Dec;31(12):556-564. doi: 10.1097/01.ASW.0000544613.10878.ed.
- Kurian S, Moore Z, Patton D, George S. The Incidence of Pressure Ulcers in Surgical Patients: A Systematic Review. Int Wound J. 2025 Aug;22(8):e70738. doi: 10.1111/iwj.70738.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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