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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Hilal Y Çelik, Lecturer, PhD
- Puhelinnumero: +90 02165004172
- Sähköposti: hilal.yildiz@acibadem.edu.tr
Opiskelupaikat
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Istanbul, Turkki (Türkiye)
- Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi
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Ottaa yhteyttä:
- Ayper Önal Alkan, RN, PhD
- Puhelinnumero: +90-533-684-94-74
- Sähköposti: ayper.alkan@live.acibadem.edu.tr
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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.
Muut nimet:
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Ei väliintuloa: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Incidence of Postoperative Pressure Injury
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of Anatomical Sites at Risk
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Ayper Önal Alkan, RN, PhD,, Acıbadem Mehmet Ali Aydınlar University
- Päätutkija: Ukke Karabacak, Professor, Acıbadem Mehmet Ali Aydınlar University
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
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- ATADEK-2026/07
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