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

V

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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