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Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma

Phase 4
18 Years
Open (Enrolling)
Breast Neoplasms, Mastectomy

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Trial Information

Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma

Background Seroma formation is a common problem after mastectomy. The incidence various
between 30% to 92%. It is often an ongoing problem after removal of the suction drain, and
repeated skin puncture is necessary to remove the seroma. In addition to many ambulatory
visits this also leads to an increased risk of infection, and the adjuvant treatment can be
delayed for several weeks

Different procedures have been tried to avoid seroma formation. Among these are for ex. :
immobilisation of the arm and shoulder after mastectomy, different drain regimens, closing
of the dead space of the cavity, different chemical substances as thrombin, tranexamacid and
fibrin. Non of these results has been successful.

Seroma formation is most likely the result of the inflammatory response due to wound
healing. In the seroma fluid several factors have been detected that support this
assumption. These factors are: high levels of IgG, leucocytes, granulocytes, proteinases,
proteinases inhibitors, different kinds of cytokines ( tPA, uPA,, uPAR, PAI-1, PAI-2, IL-6
og IL-1).

On the basis of this, an inhibition of the inflammatory response might result in a decrease
of seroma formation, and perhaps improve quality of life after mastectomy.

Steroids inhibit the inflammatory response for example by inhibition of the cytokine
function. It has been shown that a high single dose of steroid infusion (30mg/kg
solu-medrol) inhibits the normal IL 6 response after colon resection. Newer studies have
shown that even at a lower dose the inflammatory response is inhibited. In several studies
of head and neck surgery the oedema in surgical area is reduced after a single dose of 125
mg solumedrol. It is precisely this effect of reduced fluid formation we want to obtain in
our study. We have therefore chosen to use a single dose of 125 mg of solumedrol in this
study. Even at the largest single dose of glucocorticoids there have not been seen any
increasing in surgical complications.

The aim of the study: To find out whether single dose of glucocorticoid can reduce the
seroma formation after mastectomy

Study design : A randomised pilot study, with 2 x 20 patients. 125 mg solumedrol is given
1,5 hours before surgery in 20 patients, and the other 20 patients are the control group

Inclusion criteria: Women with primary breast cancer, undergoing a mastectomy with either
sentinel node biopsy or complete axillary dissection.

Inclusion Criteria:

- Women with primary breast cancer, planned for a mastectomy with and axillary

- Age over 18 years

- signed informed consent.

Exclusion Criteria:

- Men

- Treatment with glucocorticoids within the last month before surgery, including
inhalation products

- Pregnant.

- Not able to speak danish

- Severe heart disease

- Treatment with carbamazepine, phenytoin, phenobarbital, rifampicin, salicylates and

- Uræmia

- Diabetes

- Other medical conditions, evaluated by the investigator, that make tke patient unfit
for participation

- previous psychosis

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

seroma formation

Principal Investigator

Christen Axelsson

Investigator Role:

Principal Investigator


Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:




Start Date:

December 2005

Completion Date:

December 2007

Related Keywords:

  • Breast Neoplasms
  • Mastectomy
  • Mastectomy
  • Seroma
  • Breast cancer
  • Glucocorticoid
  • Breast Neoplasms
  • Neoplasms
  • Seroma