NCT01380912

Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer

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?

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Copenhagen University Hospital at Herlev · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

A randomised double-blinded study, in which the patients either get methylprednisoloneacetate or saline solution in the mastectomy cavity to evaluate the efficacy of methylprednisoloneacetate in preventing seroma in patients operated for primary breast cancer.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	methylprednisoloneacetate	Either methylprednisoloneacetate 80 mg or saline solution will be injected first day after operation, when the drain is removed.

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-08-01
• Completion: 2012-08-01
• First posted: 2011-06-27
• Last updated: 2011-06-27

Locations

2 sites across 1 country: Denmark