drugset / Trial / NCT00504582

Fibrin Melanoma Axillary Node Study in Patients With Melanoma

NCT00504582

Completed 121 enrolled M.D. Anderson Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: * To determine whether the use of a fibrin sealant applied to axillary soft tissues following node dissection can result in earlier drain removal. Secondary Objectives: * To determine the postoperative morbidity rate using fibrin sealant following axillary node dissection. * To assess patient-valuation of outcome by performing a cost-benefit analysis using a willingness-to-pay model. * To determine if serum levels, lymphatic fluids level, or cutaneous expression of vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3) correlates with nodal tumor burden or development of lymphedema in patients with melanoma.

Timeline

Start
2002-05-15
Primary completion
2020-04-09
Completion
2020-04-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Fibrinogen Concentrate Human Protein / enzyme biologic Topical

Indications