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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00852826

Enrollment

Registered

2009-02-27

Start date

2008-01-31

Completion date

2008-11-30

Last updated

2009-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seroma

Keywords

axillary seroma, axillary lymphadenectomy, morbidity, morbidity postlymphadenectomy, Lymphadenectomy

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.

Interventions

PROCEDUREStandard axillary lymphadenectomy

Standard axillary lymphadenectomy

PROCEDURECollagen 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with axillary lymphadenectomies performed for oncological conditions.

Exclusion criteria

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026