Effect of a Risk-Based Perioperative Pressure Injury Prevention Bundle in Elective Surgery Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcibadem University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Risk-Based Perioperative Pressure Injury Prevention Bundle
Other interventionA 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.
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: Risk-Based Prevention BundleExperimental treatment 1 intervention
Group B: Standard Perioperative CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of Postoperative Pressure Injury
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.
Time frame
Assessed at 24 hours after surgery (T3)Secondary outcomes
1
Number of Anatomical Sites at Risk
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.
Time frame
Assessed at 24 hours after surgery (T3)2
Protocol Adherence
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.
Time frame
Assessed throughout the perioperative period, from preoperative (T0) through 24 hours postoperative (T3)3
Incidence of Non-Blanchable Erythema
Presence of non-blanchable erythema (early sign of pressure injury) at any assessed anatomical site, recorded as Yes/No.
Time frame
Assessed preoperatively (T0), in the post-anesthesia care unit (T1), at 2-4 hours postoperative (T2), and at 24 hours postoperative (T3)Sponsors and contacts
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Source ClinicalTrials.gov
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