Effect of a Risk-Based Perioperative Pressure Injury Prevention Bundle in Elective Surgery Patients

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Conditions studied: Pressure Ulcer (PU), Pressure Injury Prevention, Perioperative Care, Braden Scale

In brief

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.

Key facts

Study ID

NCT07725068

Run by

Acibadem University

People needed

138

Starts

2026-08-01

Expected to finish

2026-12-30

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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