RecruitingNot ApplicableNCT05899387

Seroma of the Mammary Gland

Prospective, International, Multicenter Minimal Interventional Study to Detect Possible Markers for Prediction of Seroma Development and Risk Assessment of a Breast Seroma After Mastectomy with or Without Implant-based Breast Reconstruction

Sponsor

University Hospital Augsburg

Enrollment

2,000 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Mastectomy Breast Implant; Complications Seroma

Summary

The study is designed as international, prospective, minimal interventional study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists). Furthermore, it is planned to initiate a registry for postoperative breast seromas.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies the causes and prevention of fluid buildup (seroma) after breast surgery, including mastectomy with implant or tissue expander reconstruction. You may be eligible if... - You are a woman aged 18 or older - You have been diagnosed with DCIS or any stage of primary breast cancer (T1–T4, with or without lymph node involvement, non-metastatic) - You are scheduled for a mastectomy or subcutaneous mastectomy with implant or expander insertion - OR for control groups: you are scheduled for implant/expander surgery with or without mastectomy You may NOT be eligible if... - You are under 18 years old - You are male - You are planning breast-conserving surgery (lumpectomy) - You have recurrent breast cancer - You have a history of previous breast surgery - Your diagnosis is LCIS only (without other breast cancer) - You are pregnant at the time of diagnosis - You have a known immune deficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESwap collection

Performing the surgery (Mastectomy with or without implant reconstruction; Insertion of Breast implants for control group 3) according to valid standards. In addition, taking swabs intraoperatively according to protocol from skin and surgical site.

PROCEDURESeroma punction

Puncturing of a seroma in case of occurence and clinical need

PROCEDUREBlood sampling

Blood sampling at defined time points according to protocol

DIAGNOSTIC_TESTSonographic correlation Seroma

If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma

Locations(1)

University Hospital Augsburg, Department of Gynecology and Obstetrics

Augsburg, Bavaria, Germany

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NCT05899387

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