A single cohort, open trial to evaluate the efficacy and safety of TachoSil in prevention of seroma formation following axillary lymph node dissection in women following surgery for breast cancer. A pilot study. - Prevention of seroma formation following axillary lymph node dissection due to breast cancer.

• Conditions: Seroma formation in the axilla following axillary dissection of lymphnodes following surgery for breast cancer in women; MedDRA version: 7.1Level: LLTClassification code 10040102

• Registration Number: EUCTR2005-004429-25-DK
• Lead Sponsor: Viborg Sygehus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Patients with breast cancer who require exaresis of the axillary lymph nodes with or without mastectomy.
Planned removeal of lymp nodes from level I or II
Axilla must be macroscopically tumour free after dissection of lymph nodes
Age over 18 years of age
Signed informed consent before any trial related activities
Negative pregnancy test

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who have previously undergone any surgery on the breast or axilla at the planned site
Previous radiation therapy
Previous chemotherapy
Final stage patients with a life expectancy of less than 3 months
Patients with diabetes
Patients with a history of disturbances in wound healing
Known or suspected allergy to any of the components in TachoSil
Pregnancy or breast feeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective is to assess the effect and safety of TachoSil in reducing the volume of seromas following surgery for breast cancer with axillary dissection. All patients included in the trial will receive treatment with TachoSil in order to establish scientific rationale for a controlled, randomised trial.;Secondary Objective: Volume of drainage and incidence of infections in the axilla;Primary end point(s): Total volume for drainage fluid from day of surgery till follow up visit 3 months after surgery.