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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier:
NCT00852826
First received: February 26, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Seroma
 Procedure: Standard axillary lymphadenectomy
Procedure: Collagen sponge coated with human coagulation factors
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Value of a Hemostatic and Sealing Agent for Preventing Seroma After Axillary Lymphadenectomy

Resource links provided by NLM:

Drug Information available for: TachoSil
U.S. FDA Resources

Further study details as provided by Hospital Universitario Virgen de la Arrixaca:

Enrollment: 60
Study Start Date: January 2008
Estimated Study Completion Date: November 2008
Arms Assigned Interventions
Sham Comparator: 1
Standard axillary lymphadenectomy
 Procedure: Standard axillary lymphadenectomy
Standard axillary lymphadenectomy
Experimental: 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
 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
Other Name: TachoSil(R), Nycomed Pharma, AS.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with axillary lymphadenectomies performed for oncological conditions.

Exclusion Criteria:

  • Patients that did not want to participate in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852826

Locations
Spain
Hospital Universitario "Virgen de la Arrixaca"
Murcia, Spain, 30120
Sponsors and Collaborators
Hospital Universitario Virgen de la Arrixaca
Investigators
Principal Investigator: Antonio Piñero, MD PhD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00852826     History of Changes
Other Study ID Numbers: LFN001/08
Study First Received: February 26, 2009
Last Updated: February 26, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitario Virgen de la Arrixaca:
axillary seroma
axillary lymphadenectomy
morbidity
morbidity postlymphadenectomy
Lymphadenectomy

Additional relevant MeSH terms:
Seroma
Inflammation
Pathologic Processes
Hemostatics
 Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013