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Seroma of the Mammary Gland

NCT05899387 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2025-02-28

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Swap 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.

PROCEDURE

Seroma punction

Puncturing of a seroma in case of occurence and clinical need

PROCEDURE

Blood sampling

Blood sampling at defined time points according to protocol

DIAGNOSTIC_TEST

Sonographic correlation Seroma

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

Sponsors & Collaborators

  • University Hospital Augsburg

    lead OTHER

Principal Investigators

  • Thorsten Kühn, Prof. · Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany

  • Nina Ditsch, Prof. · University Hospital Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05899387 on ClinicalTrials.gov