Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer
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?
1 other identifier
observational
160
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJune 27, 2011
June 1, 2011
1 year
June 23, 2011
June 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of punctures
1 month after surgery
Study Arms (1)
breast cancer
1. Patients operated with mastectomy and axillary dissection, who are randomised to injection of methylprednisoloneacetate in the cavity 2. Patients operated with mastectomy and axillary dissection, who are randomised to injection of saline solution in the cavity 3. Patients operated with mastectomy and Sentinel Node Operation, who are randomised to injection of methylprednisoloneacetate in the cavity 4. Patients operated with mastectomy and Sentinel Node Operation, who are randomised to injection of saline solution in the cavity
Interventions
Either methylprednisoloneacetate 80 mg or saline solution will be injected first day after operation, when the drain is removed.
Eligibility Criteria
Patients operated for primary breast cancer with mastectomy and eihter axillary dissection or Sentinel Node operation
You may qualify if:
- women with primary breast cancer or Ductal carcinoma in situ, mastectomy plus either Sentinel Node or Axillary dissection, signed consent form
You may not qualify if:
- dissection of the axilla in les than 4 month, treatment with steroids, pregnancy, if the patient don't speak danish, allergy towards steroid, other medical conditions which the investigator find contradict participating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chemistry Laboratorium, Copenhagen University Hospital at Gentofte
Hellerup, DK 2900, Denmark
Department of Breast Surgery, Copenhagen University Hospital at Herlev
Herlev, 2730, Denmark
Biospecimen
seroma will be analysed for concentration of cytokines, and eventual growth of bacteria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gro M Qvamme, MD
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
August 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2012
Last Updated
June 27, 2011
Record last verified: 2011-06