Could a Bacteria-Based injection prevent implant complications?
NCT ID NCT07460297
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether an inactivated Pseudomonas aeruginosa injection, combined with an iodine wash, can reduce complications like infection and capsular contracture in women undergoing immediate breast reconstruction with implants after cancer surgery. The trial involves 100 participants and measures how quickly drainage tubes can be removed and how well the implant capsule forms. The goal is to improve recovery and patient satisfaction.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inactivated Pseudomonas aeruginosa injection (PAP) and povidone-iodine
- What this could lead to
- If it works, this could reduce infection and capsular contracture after breast reconstruction, improving recovery and satisfaction.
- What could go wrong
- This is an early-stage trial with only 100 participants, so results may not apply widely. The treatment involves a bacterial injection, which could cause unexpected inflammation or side effects.
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
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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
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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 and above * Female * Preoperative pathological confirmation of invasive breast cancer or ductal carcinoma in situ * Clinical T1 and T2 (maximum tumor diameter ≤5 cm) * Clinically negative axillary lymph nodes (clinical examination and ultrasound suggest negative axillary lymph nodes; fine needle aspiration is negative for suspected axillary lymph node abnormalities) * No clinical or radiological evidence of distant metastasis * Patients undergoing skin-sparing mastectomy or breast-conserving surgery - BMI \< 35 * Patients without lactational apoptosis or with mild breast apoptosis * Implant volume \< 500 milliliters (11) Able and willing to sign the informed consent form (ICF) Exclusion Criteria: * Breast patients with moderate to severe breast development, or patients who require subcutaneous mastectomy using Wise mode or other breast lift methods * Body mass index \>=35 * Patients who underwent symmetrical breast surgery immediately or later on the unaffected side * Patients with locally advanced breast cancer receiving neoadjuvant therapy * Patients who are currently participating in other clinical trials, which may have an impact on participation in this trial * Neoadjuvant therapy has been completed, and there is a clear indication for adjuvant radiotherapy after surgery * History of previous breast cancer (patients with ipsilateral recurrence after breast-conserving surgery) * Pregnant and lactating women * Smoking history * History of previous diabetes mellitus
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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
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Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110000, China
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Other studies related to the condition(s) this trial covers.
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