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Personalized pressure injury prevention put to the test in surgery trial

NCT ID NCT07725068

Disease control Sponsor: Acibadem University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial tests whether a risk-based prevention bundle can lower the chance of pressure injuries in patients undergoing elective surgery lasting three hours or longer. Participants are assigned to receive either standard care or a bundle tailored to their individual risk level—low, moderate, or high—based on the Braden Scale and other factors. The high-risk bundle includes silicone foam dressings on the sacrum and heels, special positioning, and pressure-relieving surfaces. The study tracks skin health before surgery, in the recovery room, and up to 24 hours after surgery to see if the bundle reduces early signs of pressure injury.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a risk-based perioperative pressure injury prevention bundle (RiPPB) including prophylactic silicone foam dressings, targeted positioning, and pressure-redistributing support surfaces
What this could lead to
If effective, this approach could reduce painful pressure injuries after surgery, improving recovery and lowering healthcare costs.
What could go wrong
This is a single-center trial with 138 participants, so results may not apply broadly. The bundle adds complexity to care, and adherence may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 138 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Surgical Wound decubitus ulcer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Braden scale Perioperative care Pressure injury prevention Pressure ulcer (PU)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi

    Istanbul, Turkey (Türkiye)

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