Seroma Control in Axillary Lymphadenectomy With Glubran 2® Without Drain. Multicenter, Prospective, Randomized Clinical Trial. GALA-ND Study (Glu Axillary Lymphadenectomy Ambulatory- no Drain)
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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. That is why the study was designed to show whether the sealant reduces seroma after axillary lymphadenectomy without drainage.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Over 18 years old
• Conservative surgery for breast cancer with associated axillary lymphadenectomy
Locations
Other Locations
Spain
Maresme health consortium
RECRUITING
Mataró
Contact Information
Primary
Sandra Lopez Gordo
slopezgord@csdm.cat
937 41 77 00
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 134
Treatments
Experimental: lymphadenectomy without drainage and with Glubran
Application of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain
No_intervention: Lymphadenectomy without drainage
No intervention required, only axillary dissection without drain
Related Therapeutic Areas
Sponsors
Leads: Omphis Foundation
Collaborators: Consorci Sanitari del Maresme