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

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.

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Key information

Conditions

Seroma Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario "Virgen de la Arrixaca"

Murcia, 30120, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with axillary lymphadenectomies performed for oncological conditions.

Exclusion criteria

Patients that did not want to participate in the study.

Treatment and study plan

Standard axillary lymphadenectomy

Procedure

Standard axillary lymphadenectomy

Collagen sponge coated with human coagulation factors

Procedure

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

Other names: TachoSil(R), Nycomed Pharma, AS.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Virgen de la Arrixaca

Other

Registry information

Official study title

Value of a Hemostatic and Sealing Agent for Preventing Seroma After Axillary Lymphadenectomy

Important dates

Study start: 2008
Study completion: 2008
First posted: Feb 27, 2009
Registry last updated: Feb 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed