Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer
|ClinicalTrials.gov Identifier: NCT01380912|
Recruitment Status : Unknown
Verified June 2011 by Copenhagen University Hospital at Herlev.
Recruitment status was: Recruiting
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: methylprednisoloneacetate|
After mastectomy, up to 90 % of patients develops seroma in the cavity. The treatment is puncture, which is a small operation, but many patients have to come several times, and there is a risk of infection. In some cases further treatment can be postponed.
Preventing seroma to develop would be an improvement in the treatment of breast cancer patients operated with mastectomy.
An earlier study found that the seroma production was significant lower in the group who had Prednison injected directly into the cavity.
In this study the patient are divided into two groups: patients who have mastectomy and axillary dissection and patients who have mastectomy and Sentinel Node operation. Each group are examined separately.
Using Prednison in patients after operation could be a potential risk, but correct injection into the cavity will seldom give systemic side effects.
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Observational Model:||Case Control|
|Official Title:||Can Injection of Methylprednisoloneacetate 80 mg, in the Cavity After Mastectomy for Primary Breast Cancer, at the Time of Removal of the Drain, Prevent Seroma Formation?|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2012|
Either methylprednisoloneacetate 80 mg or saline solution will be injected first day after operation, when the drain is removed.
- number of punctures [ Time Frame: 1 month after surgery ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380912
|Contact: Charlotte Lanng, MD||+4544884000 ext email@example.com|
|Chemistry Laboratorium, Copenhagen University Hospital at Gentofte||Recruiting|
|Hellerup, Denmark, DK 2900|
|Contact: Pal B Szecsi, MD|
|Department of Breast Surgery, Copenhagen University Hospital at Herlev||Recruiting|
|Herlev, Denmark, 2730|
|Sub-Investigator: Christen K Axelsson|
|Sub-Investigator: Birgitte Wegeberg, Nurse|
|Sub-Investigator: Minea Mortensen, Nurse|
|Sub-Investigator: Mette Okholm, MD|
|Principal Investigator:||Gro M Qvamme, MD|