[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648815":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":83,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Acibadem University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Risk-Based Prevention Bundle","EXPERIMENTAL","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\u002Foff-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).",[13],"Other: Risk-Based Perioperative Pressure Injury Prevention Bundle",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Perioperative Care","NO_INTERVENTION","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).",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"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\u002Foff-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.",[9],[25],"RiPPB",[27,31],{"name":28,"affiliation":29,"role":30},"Ayper Önal Alkan, RN, PhD,","Acıbadem Mehmet Ali Aydınlar University","STUDY_DIRECTOR",{"name":32,"affiliation":29,"role":33},"Ukke Karabacak, Professor","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":18,"email":39},"Hilal Y Çelik, Lecturer, PhD","CONTACT","+90 02165004172","hilal.yildiz@acibadem.edu.tr",[41],{"facility":42,"status":18,"city":43,"state":18,"zip":18,"country":44,"countryCode":18,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi","Istanbul","Turkey (Türkiye)",{"type":46,"coordinates":47},"Point",[48,49],28.94966,41.01384,{"lat":49,"lon":48},[52],{"name":53,"role":37,"phone":54,"phoneExt":18,"email":55},"Ayper Önal Alkan, RN, PhD","+90-533-684-94-74","ayper.alkan@live.acibadem.edu.tr",{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100648815","effect-of-a-risk-based-perioperative-pressure-injury-prevention-bundle-in-elective-surgery-patients-100648815",false,"NCT07725068","Effect of a Risk-Based Perioperative Pressure Injury Prevention Bundle in Elective Surgery Patients","Effect of a Risk-Based Perioperative Pressure Injury Prevention Bundle on Pressure Injury Development in Patients Undergoing Elective Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Scheduled to undergo elective orthopedic, general, neurosurgical, or urological surgery\n* Anticipated surgical duration greater than 3 hours\n* No pressure injury present preoperatively\n* Willing and able to provide informed consent to participate\n\nExclusion Criteria:\n\n* Existing pressure injury at enrollment\n* Undergoing emergency surgery\n* Known allergy to dressing\u002Fadhesive materials used in the prevention bundle\n* Severe dermatological condition affecting skin integrity\n* Unplanned postoperative intensive care unit admission",true,"ALL","18 Years",{"count":69,"type":70},138,"ESTIMATED","INTERVENTIONAL",[73],"NA","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.\n\nPressure 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.\n\nSkin 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.",[76,77,78,79],"Pressure Ulcer (PU)","Pressure Injury Prevention","Perioperative Care","Braden Scale",[81,82],"Surgical Wound","risk assessment","NOT_YET_RECRUITING","2026-07-21",{"date":86,"type":87},"2026-07-24","ACTUAL",{"date":89,"type":70},"2026-08-01",{"date":91,"type":70},"2026-12-30",{"name":5,"class":6},1]