NCT04904653

The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage

Randomized Controlled and Single Blind Clinical Trial in Women With Breast Cancer and Axillary Lymphadenectomy, to Evaluate the Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hemopatch is an alternative to reduce morbidity associated with axillary lymphadenectomy surgery, possibly contributing to improved patient management, clinical outcomes, and hospital costs. We propose a multicenter, controlled, and randomized trial to study the efficacy of Hemopatch in reducing serous wound drainage.

Conditions

• Hemopatch
• Breast Cancer
• Axillary Lymphadenectomy

Interventions

Type	Name	Description
DEVICE	Hemopatch	HEMOPATCH Sealing Hemostat ("HEMOPATCH") consists of a soft, thin, pliable, flexible pad of collagen derived from bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate). Due to its flexible structure, the application of HEMOPATCH to the site where hemostasis / sealing is desired is easily controlled. For differentiation, the non-coated side is marked with blue squares using a biocompatible colorant. HEMOPATCH is supplied in the following 3 sizes: * HEMOPATCH 27 x 27 mm * HEMOPATCH 45 x 45 mm * HEMOPATCH 45 x 90 mm
OTHER	Control group	No sealant (liquid, gel or patch) + suction drain

Timeline

• Start date: 2021-11-08
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-05-27
• Last updated: 2024-03-06

Locations

1 site across 1 country: Spain