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

NCT ID: NCT00852826

Last Updated: 2009-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-11-30

Brief Summary

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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

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Conditions

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Seroma

Keywords

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axillary seroma axillary lymphadenectomy morbidity morbidity postlymphadenectomy Lymphadenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Standard axillary lymphadenectomy

Group Type SHAM_COMPARATOR

Standard axillary lymphadenectomy

Intervention Type PROCEDURE

Standard axillary lymphadenectomy

2

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

Group Type EXPERIMENTAL

Collagen sponge coated with human coagulation factors

Intervention Type 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

Interventions

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Standard axillary lymphadenectomy

Standard axillary lymphadenectomy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Other Intervention Names

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TachoSil(R), Nycomed Pharma, AS.

Eligibility Criteria

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Inclusion Criteria

* Patients with axillary lymphadenectomies performed for oncological conditions.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role lead

Principal Investigators

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Antonio Piñero, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario "Virgen de la Arrixaca"

Murcia, Murcia, Spain

Site Status

Countries

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Spain

Other Identifiers

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LFN001/08

Identifier Type: -

Identifier Source: org_study_id