University Hospital Augsburg, Department of Gynecology and Obstetrics
Augsburg, Bavaria, 86156, Germany
Location status: Recruiting
NCT Number: NCT05899387
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Augsburg, Bavaria, 86156, Germany
Location status: Recruiting
Postoperative seroma formations are one of the most common and serious complications after breast surgery, above all after mastectomy. Especially in patients who have opted for breast reconstruction using implants, seromas lead to infections and wound dehiscence which can result in implant and finally breast loss. To date, the cause of seroma development has not yet been clarified. First data of a pilot study of our research group identified an association with immunological-inflammatory processes as a possible cause for seroma development (Seroma after Simple Mastectomy in Breast Cancer-The Role of CD4+ T Helper Cells and the Evidence as a Possible Specific Immune Process; Pochert et al. 2022).
The main objective of the SerMa (Seroma of the Mammary gland) study presented here is to identify patient groups who have an increased risk of developing seromas based on immunological/inflammatory processes. Based on the findings clinical consequences should be developed in the future, such as more precise risk-adapted patient education and individualized advising regarding the selection of the reconstruction procedure, with the goal of minimizing complication rates. In addition, analyses of the tumor and the microenvironment will be performed to differentiate possible carcinoma-specific immunological processes.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
study group and control group 1:
Inclusion criteria
control group 2 and 3:
Exclusion criteria
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.
Puncturing of a seroma in case of occurence and clinical need
Blood sampling at defined time points according to protocol
If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma
Time frame: Follow-up for each participant: 6 month
Time frame: Follow-up for each participant: 6 month
Time frame: Follow-up for each participant: 6 month
Time frame: Follow-up for each participant: 6 month
Contact information is provided by the study sponsor or research team.
Melitta Köpke, Dr. med.
CONTACT
Nina Ditsch, Prof.
CONTACT
University Hospital Augsburg
Other
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
Acronym: SerMa
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03305757
Aspiration, Breast Cancer
Sittard, Limburg, Netherlands
View Trial DetailsNCT03650868
Breast Cancer, Breast Diseases
Kocaeli, Turkey (Türkiye)
View Trial DetailsNCT01267552
Breast Cancer, Breast Diseases
Goiânia, Goiás, Brazil
View Trial DetailsNCT03590704
Breast Diseases, Breast Neoplasms
Rio de Janeiro, Brazil
View Trial Details