Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer
Recruitment status was Recruiting
A randomised double-blinded study, in which the patients either get methylprednisoloneacetate or saline solution in the mastectomy cavity to evaluate the efficacy of methylprednisoloneacetate in preventing seroma in patients operated for primary breast cancer.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|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?|
- number of punctures [ Time Frame: 1 month after surgery ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
seroma will be analysed for concentration of cytokines, and eventual growth of bacteria
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Either methylprednisoloneacetate 80 mg or saline solution will be injected first day after operation, when the drain is removed.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|