Clinical trial · Observational
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?
NCT01380912CI-TRIAL-00005095unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| methylprednisoloneacetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- breast cancer
- description
- 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
- interventionNames
- Drug: methylprednisoloneacetate
Primary outcomes (1)
- measure
- number of punctures
- timeFrame
- 1 month after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * women with primary breast cancer or Ductal carcinoma in situ, mastectomy plus either Sentinel Node or Axillary dissection, signed consent form Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.