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Blood tests may predict flap complications in breast reconstruction

NCT ID NCT07263347

Knowledge-focused Sponsor: Hubei Cancer Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study follows 30 women undergoing DIEP flap breast reconstruction after mastectomy. Researchers will measure inflammation and oxidative stress markers in blood samples taken before and after surgery. The goal is to understand how the body responds to the temporary loss of blood flow during the procedure, which can lead to complications. No experimental treatments are given, and participation does not change standard care.

What this could mean

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

What this could lead to
If successful, this study could help doctors better predict and prevent complications like fat necrosis after DIEP flap breast reconstruction.
What could go wrong
This is a small, early observational study with only 30 participants. It does not test any treatment, so direct benefits are unlikely, and results may not apply to all patients.

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.

Participants

About 30 people

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

Started

Dec 2025

Expected to finish

Oct 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.

Who is studied

Hospitalized adult women (18-70 years) with breast cancer at Hubei Cancer Hospital undergoing mastectomy with immediate DIEP free-flap breast reconstruction. Approximately 30 consecutive eligible patients able to provide written informed consent will be enrolled. Exclusions include severe cardiac/hepatic/renal dysfunction or severe coagulopathy, preoperative active infection, autoimmune disease or chronic immunosuppressive/anti-inflammatory therapy (e.g., corticosteroids), pregnancy or breastfeeding, and prior ipsilateral breast surgery or radiotherapy. This is an observational perioperative biomarker cohort; no investigational agents or devices are administered.

Ages

18 to 70 years

Sex

Female participants only

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: 1. Female, 18-70 years old. 2. Clinically diagnosed with breast cancer and scheduled for immediate DIEP free-flap breast reconstruction after mastectomy. 3. Conscious and able to understand and voluntarily sign written informed consent. Exclusion Criteria: 1. Severe cardiac, hepatic, or renal dysfunction or severe coagulopathy (e.g., NYHA class III-IV, Child-Pugh class C, eGFR \<30 mL/min/1.73 m²). 2. Preoperative active infection, autoimmune disease, or long-term use of immunosuppressants/anti-inflammatory drugs (e.g., corticosteroids). 3. Pregnant or breastfeeding. 4. Prior ipsilateral breast surgery or radiotherapy that may affect local blood circulation assessment. 5. Any condition deemed unsuitable by the investigator (e.g., poor compliance).

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Inflammation inflammatory disease injury ischemia reperfusion injury Postoperative Complications

As listed by the trial registrant

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

Breast neoplasms Inflammation Ischemia reperfusion injury Oxidative stress Postoperative complications Wound healing

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

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

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