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

Phase 4

Completed

• Conditions: Seroma
• Interventions: Procedure: Standard axillary lymphadenectomy; Procedure: Collagen sponge coated with human coagulation factors

• Registration Number: NCT00852826
• Lead Sponsor: Hospital Universitario Virgen de la Arrixaca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study Completion: 2008-11
• Status Verified: 2009-02
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Last Update Submitted: 2009-02-26
• Study First Posted: 2009-02-27
• Last Update Posted: 2009-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with axillary lymphadenectomies performed for oncological conditions.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Standard axillary lymphadenectomy	Standard axillary lymphadenectomy
2	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

Trial Locations

Locations (1)

Hospital Universitario "Virgen de la Arrixaca"; 🇪🇸 Murcia, Spain