Status:
RECRUITING
Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain
Lead Sponsor:
Omphis Foundation
Collaborating Sponsors:
Consorci Sanitari del Maresme
Conditions:
Seroma Following Procedure
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Axillary lymphadenectomy in breast cancer continues to be a common practice in certain patients. The use of sealants and drains continues to be a source of disagreement among the scientific community....
Detailed Description
A study has been designed to assess whether the sealant reduces the rate of symptomatic seroma measured by the number of evacuating punctures. Likewise, the decrease in volume due to the seroma betwee...
Eligibility Criteria
Inclusion
- Over 18 years old
- Conservative surgery for breast cancer with associated axillary lymphadenectomy
Exclusion
- Mastectomy
- History of axillary surgery or ipsilateral axillary radiotherapy
- ASA 4 patients. (ASA 3 patients selected)
- Lack of adequate cognitive capacity and/or signed informed consent
- Pregnancy
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT05280353
Start Date
April 1 2022
End Date
June 1 2026
Last Update
September 4 2024
Active Locations (1)
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1
Maresme health consortium
Mataró, Spain