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Can a blood pressure cuff save breast flaps? new study investigates

NCT ID NCT07487220

Disease control Sponsor: Ruhr University of Bochum Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a non-invasive procedure called remote ischemic preconditioning (RIC) could improve blood flow and reduce tissue damage in women undergoing breast reconstruction with a free flap. RIC involves using a blood pressure cuff on the upper arm to create short cycles of reduced and restored blood flow before surgery. The trial enrolled 49 participants and measured how well the transplanted tissue healed, aiming to see if this simple technique could lower the risk of complications like tissue death.

What this could mean

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

Active substance
Remote ischemic preconditioning (a non-invasive procedure using a blood pressure cuff on the upper arm)
What this could lead to
If it works, this could lead to a simple, low-cost way to improve healing and reduce complications after breast reconstruction surgery.
What could go wrong
This is a small, early-stage study with only 49 participants, so results may not apply to everyone. The procedure may not provide any benefit over standard care.

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

49 people

The number who actually took part.

Started

Apr 2021

Finished

Dec 2023

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age ≥ 18 years * Patients undergoing free flap reconstruction surgery for reconstruction of body surface defects * Treatment at the Department of Plastic Surgery, BG Universitätsklinikum Bergmannsheil Bochum * Ability to understand the study procedures * Written informed consent to participate in the study Exclusion Criteria: * Refusal or inability to provide informed consent * Contraindications to regional nerve block or perioperative procedures required for the study * Any condition that prevents participation according to investigator judgment

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Conditions

The condition(s) this trial relates to.

ischemia reperfusion injury ischemic disease

As listed by the trial registrant

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

Conditioning therapy Free flap Ischemia reperfusion injury

Contacts and locations

Locations

  • BG University Clinic Bergmannsheil

    Bochum, North Rhine-Westphalia, 44789, Germany

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Other studies related to the condition(s) this trial covers.