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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hilal Y Çelik, Lecturer, PhD
- Número de teléfono: +90 02165004172
- Correo electrónico: hilal.yildiz@acibadem.edu.tr
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi
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Contacto:
- Ayper Önal Alkan, RN, PhD
- Número de teléfono: +90-533-684-94-74
- Correo electrónico: ayper.alkan@live.acibadem.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
Otros nombres:
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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of Postoperative Pressure Injury
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Anatomical Sites at Risk
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Ayper Önal Alkan, RN, PhD,, Acıbadem Mehmet Ali Aydınlar University
- Investigador principal: Ukke Karabacak, Professor, Acıbadem Mehmet Ali Aydınlar University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ATADEK-2026/07
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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