Back to resultsEvaluation of a Hemostatic and Sealing Agent to Prevent Surgical Complications After Axillary Lymphadenectomy
Primary Purpose
Seroma
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Standard axillary lymphadenectomy
Collagen sponge coated with human coagulation factors
Sponsored by
About this trial
This is an interventional supportive care trial for Seroma focused on measuring axillary seroma, axillary lymphadenectomy, morbidity, morbidity postlymphadenectomy, Lymphadenectomy
Eligibility Criteria
Inclusion Criteria:
- Patients with axillary lymphadenectomies performed for oncological conditions.
Exclusion Criteria:
- Patients that did not want to participate in the study.
Sites / Locations
- Hospital Universitario "Virgen de la Arrixaca"
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
1
2
Arm Description
Standard axillary lymphadenectomy
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
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00852826
First Posted
February 26, 2009
Last Updated
February 26, 2009
Sponsor
Hospital Universitario Virgen de la Arrixaca
1. Study Identification
Unique Protocol Identification Number
NCT00852826
Brief Title
Evaluation of a Hemostatic and Sealing Agent to Prevent Surgical Complications After Axillary Lymphadenectomy
Official Title
Value of a Hemostatic and Sealing Agent for Preventing Seroma After Axillary Lymphadenectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitario Virgen de la Arrixaca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma
Keywords
axillary seroma, axillary lymphadenectomy, morbidity, morbidity postlymphadenectomy, Lymphadenectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Sham Comparator
Arm Description
Standard axillary lymphadenectomy
Arm Title
2
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Standard axillary lymphadenectomy
Intervention Description
Standard axillary lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
Collagen sponge coated with human coagulation factors
Other Intervention Name(s)
TachoSil(R), Nycomed Pharma, AS.
Intervention Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with axillary lymphadenectomies performed for oncological conditions.
Exclusion Criteria:
Patients that did not want to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Piñero, MD PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario "Virgen de la Arrixaca"
City
Murcia
ZIP/Postal Code
30120
Country
Spain
12. IPD Sharing Statement
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Evaluation of a Hemostatic and Sealing Agent to Prevent Surgical Complications After Axillary Lymphadenectomy
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