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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004429-25-DK

Enrollment

Registered

2005-11-25

Start date

2006-10-31

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seroma formation in the axilla following axillary dissection of lymphnodes following surgery for breast cancer in women MedDRA version: 7.1 Level: LLT Classification code 10040102

Interventions

Trade Name: TachoSil Product Name: TachoSil Product Code: Local haemostatics Pharmaceutical Form: Medicated plaster

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026