Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma

NCT00307606 | Unknown Phase 4 DMC

• 1 other identifier: seromprotocol
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Mastectomy

Keywords

Mastectomy; Seroma; Breast cancer; Glucocorticoid

Outcome Measures

Primary Outcomes (1)

• seroma formation

Interventions

Solu-medrol 125 mg DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with primary breast cancer, planned for a mastectomy with and axillary dissection.
• Age over 18 years
• signed informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital, breast surgery

Herlev, Copenhagen, 2730, Denmark

RECRUITING

Related Publications (34)

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MeSH Terms

Conditions

Breast Neoplasms; Seroma

Interventions

Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Christen Axelsson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 28, 2006
• Study Start: December 1, 2005
• Study Completion: December 1, 2007
• Last Updated: September 6, 2007

Record last verified: 2005-12

Locations

DK (1)