NCT05280353

Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Omphis Foundation · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 between the two groups and the quality of life of the patients is assessed, given that none of them has a drain

Conditions

• Seroma Following Procedure

Interventions

Type	Name	Description
OTHER	Glubran 2	Application of Glubran 2 sealant (liquid) in axillary hollow

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2022-03-15
• Last updated: 2024-09-04

Locations

1 site across 1 country: Spain