Pressure Ulcer (PU)RiPPBNCT07725068
Effect of a Risk-Based Perioperative Pressure Injury Prevention Bundle in Elective Surgery Patients
A study testing Risk-Based Perioperative Pressure Injury Prevention Bundle in people with Pressure Ulcer (PU) and Pressure Injury Prevention, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer (PU), Pressure Injury Prevention, Perioperative Care
- What is being tested?
- Risk-Based Perioperative Pressure Injury Prevention Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi
Istanbul
Ayper Önal Alkan, RN, PhD, +90-533-684-94-74, ayper.alkan@live.acibadem.edu.tr
About this study
Official title: 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.
Read the 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.
- Being tested
- Risk-Based Perioperative Pressure Injury Prevention Bundle
- Keywords
- Surgical Wound, risk assessment
- Medical subject headings
- Pressure Ulcer, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-Based Perioperative Pressure Injury Prevention BundleOther
Also called RiPPB
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at 24 hours after surgery (T3)
Secondary outcomes (3)
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.
Measured: Assessed at 24 hours after surgery (T3)
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.
Measured: Assessed throughout the perioperative period, from preoperative (T0) through 24 hours postoperative (T3)
Incidence of Non-Blanchable Erythema
Presence of non-blanchable erythema (early sign of pressure injury) at any assessed anatomical site, recorded as Yes/No.
Measured: Assessed preoperatively (T0), in the post-anesthesia care unit (T1), at 2-4 hours postoperative (T2), and at 24 hours postoperative (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion12 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pressure Ulcer (PU)Studies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayper Önal Alkan, RN, PhD,, Study director, Acibadem UniversityUkke Karabacak, Professor, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725068
- Sponsor's protocol ID
- ATADEK-2026/07
- Acronym
- RiPPB
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 30475284Kurian 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.
PubMed 40825923
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Risk-Based Perioperative Pressure Injury Prevention Bundle on Pressure Injury Development in Patients Undergoing Elective Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07725068
- Acronym / sponsor ID
- RiPPB / ATADEK-2026/07
- Keywords
- Surgical Wound, risk assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Risk-Based Prevention Bundle | Experimental | Other: Risk-Based Perioperative Pressure Injury Prevention BundleParticipants 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). |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-Based Perioperative Pressure Injury Prevention BundleAlso: RiPPBA 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 | Risk-Based Prevention Bundle |
Primary outcome
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.
3 secondary outcomes
Number of Anatomical Sites at Risk
Time frame: Assessed at 24 hours after surgery (T3)
Protocol Adherence
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 30475284Bulfone 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.
- Background: PubMed 40825923Kurian 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Pressure Ulcer (PU)
Not yet recruitingPhase 1/2
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Lower Extremity, Chronic Ulcers
Enrolling by invitation
The Effect of Photobiomodulation on Pressure Ulcers
Pressure Ulcer (PU)
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
Active, not recruitingObservational study
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Not yet recruiting
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
Leg Ulcer, Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayper Önal Alkan, RN, PhD, study director
Acibadem University
Ukke Karabacak, Professor principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk-Based Perioperative Pressure Injury Prevention Bundle in people with Pressure Ulcer (PU) and Pressure Injury Prevention, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilal Y Çelik, Lecturer, PhD (+90 02165004172, hilal.yildiz@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Pressure Injury (time frame: Assessed at 24 hours after surgery (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07725068, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.