Clinical trial · Interventional
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
NCT05899387CI-TRIAL-00086640SerMarecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Implant; Complications | — | UNRESOLVED | — |
| Mastectomy | — | UNRESOLVED | — |
| Seroma | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Procedure | — | UNRESOLVED |
| Seroma punction | Procedure | — | UNRESOLVED |
| Sonographic correlation Seroma | Diagnostic Test | — | UNRESOLVED |
| Swap collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- BC, mastectomy and implant
- description
- Women with first diagnosis of breast cancer or DCIS and planned skin-sparing mastectomy and implant placement
- interventionNames
- Procedure: Swap collection
- Procedure: Seroma punction
- Procedure: Blood sampling
- Diagnostic Test: Sonographic correlation Seroma
- type
- ACTIVE_COMPARATOR
- label
- BC and mastectomy
- description
- Women with first diagnosis of breast cancer or DCIS and planned simple mastectomy
- interventionNames
- Procedure: Swap collection
- Procedure: Seroma punction
- Procedure: Blood sampling
- Diagnostic Test: Sonographic correlation Seroma
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria study group and control group 1: * 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 Inclusion criteria control group 2 and 3: * Written informed consent * Age ≥ 18 years * Surgical procedure planned with implant or expander insertion with or without subcutaneous mastectomy Exclusion criteria: * Age \<18 years * Male sex * Breast cancer patients planned for breast conserving therapy * Recurrent breast cancer disease * History of breast surgery * Diagnosis of LCIS only * Pregnancy at time of diagnosis * Patients with a known immunodeficiency
References
Publications (0)
Data not yet available
No reference posted for this study.