Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma

Sponsor

Herlev Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00307606

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Mastectomy	Drug: Solu-medrol 125 mg	Phase 4

Detailed Description

Different procedures have been tried to avoid seroma formation. Among these are for ex. :

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma

Study Start Date :

Dec 1, 2005

Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

seroma formation []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women with primary breast cancer, planned for a mastectomy with and axillary dissection.
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 ciclosporin
Uræmia
Diabetes
Other medical conditions, evaluated by the investigator, that make tke patient unfit for participation
previous psychosis