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?

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01380912

Enrollment

160

Registered

2011-06-27

Start date

2010-08-31

Completion date

2012-08-31

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, mastectomy, methylprednisoloneacetate, seroma, numbers of punctures

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.

Detailed description

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.

Interventions

DRUGmethylprednisoloneacetate

Either methylprednisoloneacetate 80 mg or saline solution will be injected first day after operation, when the drain is removed.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
number of punctures	1 month after surgery

Countries

Denmark

Contacts

Primary ContactCharlotte Lanng, MD

chalan01@heh.regionh.dk+4544884000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026