Clinical Trials Directory

Trials / Completed

CompletedNCT00852826

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Hospital Universitario Virgen de la Arrixaca · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREStandard axillary lymphadenectomyStandard axillary lymphadenectomy
PROCEDURECollagen sponge coated with human coagulation factorsThree 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

Timeline

Start date
2008-01-01
Completion
2008-11-01
First posted
2009-02-27
Last updated
2009-02-27

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT00852826. Inclusion in this directory is not an endorsement.