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

NCT07725068 | Not Yet Recruiting

• 1 other identifier: ATADEK-2026/07
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Ulcer (PU); Pressure Injury Prevention; Perioperative Care; Braden Scale

Keywords

Surgical Wound; risk assessment

Outcome Measures

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.

  Assessed at 24 hours after surgery (T3)

Secondary Outcomes (3)

• Number of Anatomical Sites at Risk

  Assessed at 24 hours after surgery (T3)

• Protocol Adherence

  Assessed throughout the perioperative period, from preoperative (T0) through 24 hours postoperative (T3)

• Incidence of Non-Blanchable Erythema

  Assessed preoperatively (T0), in the post-anesthesia care unit (T1), at 2-4 hours postoperative (T2), and at 24 hours postoperative (T3)

Study Arms (2)

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/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

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).

Interventions

Risk-Based Perioperative Pressure Injury Prevention Bundle OTHER

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.

Also known as: RiPPB

Risk-Based Prevention Bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Bulfone G, Bressan V, Morandini A, Stevanin S. Perioperative Pressure Injuries: A Systematic Literature Review. Adv Skin Wound Care. 2018 Dec;31(12):556-564. doi: 10.1097/01.ASW.0000544613.10878.ed.

  PMID: 30475284 BACKGROUND

• Kurian S, Moore Z, Patton D, George S. The Incidence of Pressure Ulcers in Surgical Patients: A Systematic Review. Int Wound J. 2025 Aug;22(8):e70738. doi: 10.1111/iwj.70738.

  PMID: 40825923 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer; Surgical Wound

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Ayper Önal Alkan, RN, PhD,

  Acıbadem Mehmet Ali Aydınlar University

  STUDY DIRECTOR

• Ukke Karabacak, Professor

  Acıbadem Mehmet Ali Aydınlar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilal Y Çelik, Lecturer, PhD

CONTACT

+90 02165004172; hilal.yildiz@acibadem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly allocated in a 1:1 ratio to either the risk-based perioperative pressure injury prevention bundle (intervention arm) or standard perioperative care (control arm), and followed in parallel through four assessment time points (preoperative, PACU, 2-4 hours postoperative, and 24 hours postoperative).

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)