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| Name | Class |
|---|---|
| University Hospital, Gentofte, Copenhagen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| breast cancer |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisoloneacetate | Drug | Either methylprednisoloneacetate 80 mg or saline solution will be injected first day after operation, when the drain is removed. |
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| Measure | Description | Time Frame |
|---|---|---|
| number of punctures | 1 month after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients operated for primary breast cancer with mastectomy and eihter axillary dissection or Sentinel Node operation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Lanng, MD | Contact | +4544884000 | 89265 | chalan01@heh.regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Gro M Qvamme, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chemistry Laboratorium, Copenhagen University Hospital at Gentofte | Recruiting | Hellerup | DK 2900 | Denmark |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D049291 | Seroma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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seroma will be analysed for concentration of cytokines, and eventual growth of bacteria
| Department of Breast Surgery, Copenhagen University Hospital at Herlev | Recruiting | Herlev | 2730 | Denmark |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |