Health TrialsbyHealthPanel

Seroma of the Mammary Gland

ConditionsSeromaBreast CancerMastectomyBreast Implant; Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital Augsburg

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Written informed consent

Age ≥ 18 years

all stages of DCIS or primary breast cancer (T1-T4, N0 or N+, M0) including all histopathological subtypes (ER/PR positive, ER positive/PR negative, Her-2/neu positive and triple negative)

Surgical procedure planned including ablatio or subcutaneous mastectomy with implant or expander insertion

Disqualifiers

Age <18 years

Male sex

Breast cancer patients planned for breast conserving therapy

Recurrent breast cancer disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Swap collection

    Procedure/Surgery

    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.

  • Seroma punction

    Procedure/Surgery

    Puncturing of a seroma in case of occurence and clinical need

  • Blood sampling

    Procedure/Surgery

    Blood sampling at defined time points according to protocol

  • Sonographic correlation Seroma

    Diagnostic test

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

Treatment groups

2,000 Participants
are divided into 4 treatment groups
Group A: BC, mastectomy and implantExperimental treatment 4 interventions
Group B: BC and mastectomyActive comparator 4 interventions
Group C: High risk for BCActive comparator 4 interventions
Group D: Cosmetic breast surgeryActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Identification of a patient population at increased risk for developing seroma.

* Examination of seroma fluid and blood samples to identify immunological markers. * Local microbiome analyses to investigate a possible bacterial colonization. * Tissue analyses to determine possible carcinoma-specific immunologic processes.

Time frame
Follow-up for each participant: 6 month

Secondary outcomes

1

Comparison of findings in local and systemic measurements in patients with and without seroma.

Time frame
Follow-up for each participant: 6 month
2

Comparison of the groups with or without cancer regarding development of seroma.

Time frame
Follow-up for each participant: 6 month
3

Comparison of the clinicopathologic differences between the implant and simple mastectomy group within both cancer groups

Time frame
Follow-up for each participant: 6 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Augsburg

Lead sponsor

Source ClinicalTrials.gov
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