Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer
Information source: Copenhagen University Hospital at Herlev
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: methylprednisoloneacetate (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Copenhagen University Hospital at Herlev Official(s) and/or principal investigator(s):
Gro M Qvamme, MD, Principal Investigator
Overall contact:
Charlotte Lanng, MD, Phone: +4544884000, Ext: 89265, Email: chalan01@heh.regionh.dk
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.
Clinical Details
Official title: 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?
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: number of punctures
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- women with primary breast cancer or Ductal carcinoma in situ, mastectomy plus either
Sentinel Node or Axillary dissection, signed consent form
Exclusion Criteria:
- dissection of the axilla in les than 4 month, treatment with steroids, pregnancy, if
the patient don't speak danish, allergy towards steroid, other medical conditions
which the investigator find contradict participating
Locations and Contacts
Charlotte Lanng, MD, Phone: +4544884000, Ext: 89265, Email: chalan01@heh.regionh.dk
Chemistry Laboratorium, Copenhagen University Hospital at Gentofte, Hellerup DK 2900, Denmark; Recruiting
Pal B Szecsi, MD
Department of Breast Surgery, Copenhagen University Hospital at Herlev, Herlev 2730, Denmark; Recruiting
Christen K Axelsson, Sub-Investigator
Birgitte Wegeberg, Nurse, Sub-Investigator
Minea Mortensen, Nurse, Sub-Investigator
Mette Okholm, MD, Sub-Investigator
Additional Information
Starting date: August 2010
Last updated: June 23, 2011
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