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

Qualifiers

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

Treatments tested in this trial

  • Risk-Based Perioperative Pressure Injury Prevention Bundle

Treatment groups

138 Participants
are divided into 2 treatment groups

Sponsors and collaborators