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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014