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Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma
This study is currently recruiting participants.
Study NCT00307606   Information provided by Herlev Hospital
First Received: March 27, 2006   Last Updated: September 5, 2007   History of Changes

March 27, 2006
September 5, 2007
December 2005
 
seroma formation
Same as current
Complete list of historical versions of study NCT00307606 on ClinicalTrials.gov Archive Site
 
 
 
Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma
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.

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.

Phase IV
Interventional
Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
  • Breast Neoplasms
  • Mastectomy
Drug: Solu-medrol 125 mg
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
December 2007
 

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
Female
18 Years and older
No
 
Denmark
 
NCT00307606
 
seromprotocol
Herlev Hospital
 
Principal Investigator: Christen Axelsson Unaffiliated
Herlev Hospital
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP