Evaluation of a Hemostatic and Sealing Agent to Prevent Surgical Complications After Axillary Lymphadenectomy

Virgen de la Arrixaca University Clinical Hospital (HCUVA)

Status and phase: Completed; Phase 4

Conditions: Seroma

Treatments: Procedure: Standard axillary lymphadenectomy; Procedure: Collagen sponge coated with human coagulation factors

Study type: Interventional

Funder types: Other

Identifiers

NCT00852826

LFN001/08

Details and patient eligibility

About

This study was intended to assess the value of a hemostatic and sealing agent, a collagen sponge coated with human coagulation factors (fibrinogen and thrombin) (TachoSil®), for decreasing occurrence of seroma after axillary lymphadenectomy.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with axillary lymphadenectomies performed for oncological conditions.

Exclusion criteria

• Patients that did not want to participate in the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

1

Sham Comparator group

Description:

Standard axillary lymphadenectomy

Treatment:

Procedure: Standard axillary lymphadenectomy

2

Experimental group

Description:

Three patches of collagen sponge coated with human coagulation factors (TachoSil®, Nycomed Pharma, AS) were perpendicularly placed at the end of lymphadenectomy on the axillary neurovascular bundle, thoracodorsal pedicle, and costal wall, covering the axillary walls

Treatment:

Procedure: Collagen sponge coated with human coagulation factors