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

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ClinicalTrials.gov Identifier: NCT00852826
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : February 27, 2009
Sponsor:
Information provided by:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Value of a Hemostatic and Sealing Agent for Preventing Seroma After Axillary Lymphadenectomy
Study Start Date : January 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00852826     History of Changes
Other Study ID Numbers: LFN001/08
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: February 27, 2009
Last Verified: February 2009

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