| NCT ID | NCT05899387 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Augsburg |
| Condition | Seroma |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,000 participants in total. It began in 2024-04-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Thorsten Kühn, Prof.
STUDY CHAIR
Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany
Frequently Asked Questions
Who can join the NCT05899387 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Seroma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05899387 currently recruiting?
Yes, NCT05899387 is actively recruiting participants. Contact the research team at nina.ditsch@uk-augsburg.de for enrollment information.
Where is the NCT05899387 trial being conducted?
This trial is being conducted at Augsburg, Germany.
Who is sponsoring the NCT05899387 clinical trial?
NCT05899387 is sponsored by University Hospital Augsburg. The principal investigator is Thorsten Kühn, Prof. at Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany. The trial plans to enroll 2,000 participants.