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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?


N/A
18 Years
90 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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?


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

number of punctures

Outcome Time Frame:

1 month after surgery

Safety Issue:

Yes

Principal Investigator

Gro M Qvamme, MD

Investigator Role:

Principal Investigator

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

H-4-2009-137

NCT ID:

NCT01380912

Start Date:

August 2010

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • breast cancer
  • mastectomy
  • methylprednisoloneacetate
  • seroma
  • numbers of punctures
  • Breast Neoplasms
  • Seroma

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