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

July 21, 2026 updated by: Acibadem University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: 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/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.
Other Names:
  • RiPPB
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative Pressure Injury
Time Frame: Assessed at 24 hours after surgery (T3)
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.
Assessed at 24 hours after surgery (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Anatomical Sites at Risk
Time Frame: Assessed at 24 hours after surgery (T3)
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.
Assessed at 24 hours after surgery (T3)
Protocol Adherence
Time Frame: Assessed throughout the perioperative period, from preoperative (T0) through 24 hours postoperative (T3)
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.
Assessed throughout the perioperative period, from preoperative (T0) through 24 hours postoperative (T3)
Incidence of Non-Blanchable Erythema
Time Frame: Assessed preoperatively (T0), in the post-anesthesia care unit (T1), at 2-4 hours postoperative (T2), and at 24 hours postoperative (T3)
Presence of non-blanchable erythema (early sign of pressure injury) at any assessed anatomical site, recorded as Yes/No.
Assessed preoperatively (T0), in the post-anesthesia care unit (T1), at 2-4 hours postoperative (T2), and at 24 hours postoperative (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Study Director: Ayper Önal Alkan, RN, PhD,, Acıbadem Mehmet Ali Aydınlar University
  • Principal Investigator: Ukke Karabacak, Professor, Acıbadem Mehmet Ali Aydınlar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 12, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 21, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK-2026/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available due to institutional data protection policies and the absence of a current data-sharing agreement. De-identified data may be made available upon reasonable request to the corresponding author, subject to institutional approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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