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NCT00852826 Clinical Trial

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

Seroma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00852826
Other study ID # LFN001/08
Secondary ID
Status Completed
Phase Phase 4
First received February 26, 2009
Last updated February 26, 2009
Start date January 2008
Est. completion date November 2008

Study information
Verified date February 2009
Source Hospital Universitario Virgen de la Arrixaca
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date November 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with axillary lymphadenectomies performed for oncological conditions.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Spain Hospital Universitario "Virgen de la Arrixaca" Murcia

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

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